ClotTriever Catheter, 16 mm 40-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00850291007093), received between Dec 5, 2017 and Mar 20, 2026 — classified as 11 deaths, 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 60-YEAR-OLD FEMALE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. AFTER COMPLETING THE FIRST PASS AND CLEANING THE CLOTTRIEVER CATHETER, THE PATIENT DETERIORATED. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS INITIATED AND THE PATIENT'S CONDITION IMPROVED. CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A MILD PULMONARY EMBOLISM (PE) THE FOLLOWING DAY, THE PATIENT WAS WEANED OFF PCPS. THREE DAYS FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO A GENERAL WARD AND BEGAN REHABILITATION. ONE WEEK FOLLOWING THE THROMBECTOMY, CT IMAGING SHOWED REMARKABLE IMPROVEMENT IN BOTH THE PATIENT'S DVT AND PE. THE PATIENT WAS SCHEDULED FOR DISCHARGE ON (B)(6) 2026.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pulmonary Embolism

  MAUDE report 24654450 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD FEMALE PRESENTED WITH RIGHT LEG DEEP VEIN THROMBOSIS (DVT) AFTER UNDERGOING KNEE SURGERY 2 WEEKS PRIOR. THROMBUS WAS VISUALIZED THROUGHOUT THE FEMORAL VEIN AND EITHER IN OR BEHIND A VENOUS STENT. A COMPUTED TOMOGRAPHY SCAN PERFORMED 2 DAYS BEFORE THE DVT PROCEDURE REVEALED THAT THE PATIENT ALSO HAD MINOR PULMONARY EMBOLISM WITH NO RIGHT HEART STRAIN. THE DECISION WAS MADE TO USE A TRIEVER20 (T20) TO PERFORM ASPIRATIONS TO ADDRESS THE DVT. MULTIPLE ASPIRATIONS WERE PERFORMED WHICH YIELDED CLOT. ONCE THE T20 MADE IT TO THE COMMON FEMORAL VEIN, ADDITIONAL ASPIRATION WAS PERFORMED AND ONCE NO MORE CLOT COULD BE REMOVED, THE CATHETER WAS BROUGHT BACK TO THE POPLITEAL TO DO A VENOGRAM. THIS REVEALED NO MORE CLOT ALL THE WAY TO THE INFERIOR VENA CAVA. AT THIS MOMENT, THE PATIENT BECAME TACHYCARDIC AND BEGAN TO DETERIORATE. THE PATIENT BECAME UNRESPONSIVE AND THE T20 WAS REMOVED. THE PATIENT WAS PLACED SUPINE ON A STRETCHER TO PERFORM THE ADVANCED CARDIAC LIFE SUPPORT PROTOCOL. A CODE WAS CALLED AND AFTER 15-30 MINUTES OF CODING, THE PATIENT ESTABLISHED BLOOD PRESSURE AND RHYTHM. A BOLUS OF TPA WAS ADMINISTERED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. UNFOR

  Patient problems: Pulmonary Embolism

  MAUDE report 22299779 ↗
• InjuryNov 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INARI RECEIVED A VOLUNTARY MEDWATCH REPORT (#MW5146512) WHICH STATED "INARI THROMBECTOMY DEVICE USED IN SVC/BRACHIOCEPHALIC TRUNK TO REMOVE SUSPECTED CLOT BURDEN. SVC [SUPERIOR VENA CAVA] WAS DISSECTED AND HOLE INTO THE PERICARDIUM. PATIENT LOST PULSES, CPR WAS ADMINISTERED. PATIENT WAS INTUBATED. PERICARDIOCENTESIS WAS PERFORMED VIA ECHO [ECHOCARDIOGRAM] WHICH SHOWED THE RV [RIGHT VENTRICLE] WAS BARELY FUNCTIONING. 250CC'S OF BLOOD WAS TAKEN OFF OF THE HEART".

  Patient problems: Cardiac Arrest; Cardiac Perforation; Diminished Pulse Pressure; Pericardial Effusion; Respiratory Arrest; Vascular Dissection

  MAUDE report 18196734 ↗
• DeathFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 55-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH LEFT LEG ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT). THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY WITH THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM ON (B)(6) 2023; AT THE TIME OF SURGERY, THE CLOT AGE WAS ESTIMATED AT 5 DAYS. THE CT SHEATH WAS PLACED IN THE PATIENT AND THE CT CATHETER WAS ADVANCED. THE CORING ELEMENT WAS PLACED AT THE TOP OF THE ILIACS STARTING IN THE INTRA VENA CAVA (IVC). THE PHYSICIAN INITIATED THE FIRST PASS AND THE CT CATHETER MOVED 2 CM BEFORE FEELING RESISTANCE. THE CT CATHETER WAS RE-SHEATHED INSIDE OF THE PATIENT AND REMOVED. FOLLOWING THE REMOVAL, THE PHYSICIAN BALLOONED THE ILLIACS AT 3 LOCATIONS WITH A 13 MM X 40 MM BALLOON. THE CT CATHETER WAS INSERTED AGAIN, AND 3 PASSES WERE PERFORMED, BUT THIS EFFORT YIELDED NO CLOT. A PIGTAIL CATHETER WAS THEN INSERTED AND A DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THERE WAS NO CLOT PRESENT. AT THIS POINT, THE PATIENT REPORTED DIFFICULTY BREATHING AND HER OXYGENATION (SPO2) DECREASED FROM 100% TO 84%. THE PHYSICIAN ATTEMPTED TO STENT THE ILIACS WHEN THE PATIENT VOMITED AND LOST CONSCIOUSNESS. A CODE WAS INITIATED, AN

  Patient problems: Cardiac Arrest; Cardiovascular Dysfunction/Insufficiency; Dyspnea; Loss of consciousness; Low Oxygen Saturation; Pulmonary Embolism; Vomiting

  MAUDE report 16421595 ↗
• DeathNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 27-YEAR-OLD OBESE FEMALE PATIENT PRESENTED WITH MINIMAL SWELLING OF THE LEFT LEG. THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS (DVT) IN HER LEFT LEG, AND IT WAS REVEALED SHE HAD A PRIOR DVT IN THE SAME LEG. A THROMBECTOMY WAS SCHEDULED FOR (B)(6) 2022 USING THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM. GENERAL ANESTHESIA AND A BOLUS OF HEPARIN WERE ADMINISTERED AND ACCESS WAS GAINED. THE POPLITEAL VEIN WAS IMAGED, AND WIRE POSITION WAS OBTAINED WITH THE SUPRA CORE 300 CM GUIDEWIRE. THE CLOTTRIEVER (CT) SHEATH 13 FR WAS PREPARED AND THE ACCESS SITE WAS DILATED WITH A 13 FR DILATOR. THE CT SHEATH WAS INSERTED AND THE FUNNEL DEPLOYED SUCCESSFULLY. A CATHETER WAS THEN INSERTED TO IMAGE THE SUBCLAVIAN AND ILIAC. THE CLOTTRIEVER CATHETER WAS INSERTED OVER THE GUIDEWIRE AND THE CORING ELEMENT WAS DEPLOYED IN THE LOWER INFERIOR VENA CAVA. DURING THE FIRST PASS, THE PHYSICIAN ENCOUNTERED "MODERATE RESISTANCE". WHILE CLEANING CLOT FROM THE CORING ELEMENT, THE PATIENT'S SYSTOLIC BLOOD PRESSURE (BP) DECREASED TO THE 50 RANGE AND A FAINT PULSE WAS DETECTED. WITHIN 2 MINUTES, THE PATIENT WAS REPOSITIONED, CHEST COMPRESSIONS WERE INITIATED, AND 50 MG OF TPA WAS ADMINISTERED . RESUSCI

  Patient problems: Bradycardia; Cardiac Arrest; Embolism/Embolus; Low Blood Pressure/ Hypotension

  MAUDE report 15811743 ↗
• DeathOct 21, 2022Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  A 53-YEAR-OLD MALE PATIENT PRESENTED WITH A CLOTTED INFERIOR VENA CAVA (IVC) FILTER WITH THE DEEP VEIN THROMBOSIS (DVT) EXTENDING TO THE LEFT POPLITEAL VEIN. THE PATIENT EXPERIENCED A PREVIOUS ADVERSE EVENT FROM AN ARTERIAL PROCEDURE AND THE RIGHT LEG VEINS WERE LIGATED. ON (B)(6) 2022, THE PATIENT UNDERWENT A THROMBECTOMY USING THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM. DUE TO THE RIGHT LEG BEING LIGATED, THE INTERVENTIONAL CARDIOLOGIST ELECTED TO PLACE A LONG SHEATH FROM THE INTERNAL JUGULAR (IJ) VEIN DOWN TO PREVENT THE CT COLLECTION BAG FROM INTERACTING WITH THE FILTER. THE WIRE WAS SUCCESSFULLY EXTERNALIZED FROM BOTH ACCESS POINTS, BUT THE SHEATH WAS UNABLE TO BE COMPLETELY DELIVERED BEYOND THE FILTER. THE PROCEDURE CONTINUED, AND 2 SUCCESSFUL PASSES WERE MADE WITH THE CT CATHETER WHICH PRODUCED SIGNIFICANT CLOT YIELD. HOWEVER, ON THE THIRD PASS, THE CT COLLECTION BAG CAUGHT ON THE FILTER AND SLOWLY PULLED THE FILTER TOWARDS THE LEFT COMMON ILIAC VEIN (LCIV). AT THIS POINT APPROXIMATELY 70% OF THE CLOT HAD BEEN EVACUATED AND THE PHYSICIAN REMOVED THE IVC FILTER FROM THE IJ. ALTHOUGH THE IVC REMOVAL WAS ACCOMPLISHED WITHOUT DAMAGING THE CT COLLECTION BAG, THE PATIENT DETER

  Patient problems: Cardiac Arrest; Pulmonary Embolism; Tachycardia

  MAUDE report 15655261 ↗
• InjuryJul 13, 2022Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  A (B)(6) MALE PRESENTED TO THE EMERGENCY DEPARTMENT WITH RIGHT LEG SWELLING AND PAIN. ULTRASOUND CONFIRMED DEEP VEIN THROMBOSIS (DVT) OF THE RIGHT COMMON FEMORAL, RIGHT POPLITEAL, AND RIGHT DEEP FEMORAL VEINS. THE CLOT WAS CHRONIC (AGED APPROXIMATELY 30 DAYS) AND THE PATIENT HAD BEEN SYMPTOMATIC FOR APPROXIMATELY 10 DAYS. ON (B)(6) 2022, THE INARI MEDICAL CLOTTRIEVER (CT) SYSTEM, COMPRISED OF THE CT CATHETER AND CT SHEATH (13 FR), WAS USED TO TREAT THE DVT. THE PATIENT WAS GIVEN SYSTEMIC HEPARIN AND PLACED IN THE PRONE POSITION AND THE RIGHT POPLITEAL VEIN WAS ACCESSED WITH A 5 FR MICROPUNCTURE KIT UNDER ULTRASOUND GUIDANCE. THE MICROPUNCTURE SHEATH WAS EXCHANGED FOR AN 8 FR TERUMO PINNACLE SHEATH, AND AN 0.035" GLIDEWIRE ADVANTAGE (260CM) WAS NAVIGATED INTO THE INFERIOR VENA CAVA (IVC). A 100 CM BERENSTEIN DIAGNOSTIC CATHETER WAS ADVANCED OVER THE GUIDEWIRE AND INTRODUCED INTO THE RIGHT DISTAL FEMORAL VEIN. SELECTIVE ANGIOGRAMS WERE PERFORMED FROM THE FEMORAL VEIN TO THE IVC. THROMBUS WAS OBSERVED THROUGHOUT THE FEMORAL VEIN AND INTO THE COMMON FEMORAL VEIN AND THE WIRE WAS DELIVERED TO THE RIGHT SUBCLAVIAN VEIN. ANGIOPLASTY WAS PERFORMED IN THE POPLITEAL VEIN USING A MUSTANG 8X40

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 15009213 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A 61-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT COMPLAINING OF LEFT LEG PAIN. THE PATIENT WAS DIAGNOSED WITH UNILATERAL DVT IN THE LEFT LEG AND A MILD PULMONARY EMBOLISM. THE CT ANGIOGRAM REVEALED A VERY SMALL AMOUNT OF CLOT BURDEN IN THE LOWER RIGHT AND LEFT PULMONARY ARTERIES. NO CLOT WAS OBSERVED IN THE MAIN PULMONARY ARTERIES AND THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2022 WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM TO ADDRESS HER DEEP VEIN THROMBOSIS (DVT). THE PATIENT WAS INTUBATED FOR THE PROCEDURE AND ACCESS WAS GAINED ON THE LEFT POPLITEAL VEIN WITH ULTRASOUND; THERE WAS NO CLOT IN THE POPLITEAL VEIN. A VENOGRAM WAS PERFORMED OF THE COMMON FEMORAL VEIN INTO THE COMMON ILIAC INTO THE INFERIOR VENA CAVA (IVC) WITH NO CLOT TO THE CONFLUENCE. CLOT BURDEN WAS FOUND IN BOTH THE COMMON FEMORAL, COMMON ILIAC, AND RIGHT AT THE CONFLUENCE ON THE LEFT SIDE. THE PHYSICIAN CONTINUED TO WIRE UP TO THE SUBCLAVIAN VEIN WITH AN ADVANTAGE GLIDE WIRE. ONCE WIRE POSITIONING WAS OBTAINED IN THE SUBCLAVIAN VEIN, THE CLOTTRIEVER SHEATH WAS PLACED, AND THE VEIN WAS DILATED USING A 16 FR DILATOR. THE CLOT

  Patient problems: Bone Fracture(s); Cardiac Arrest; Embolism/Embolus; Low Oxygen Saturation; Pulmonary Edema; Respiratory Arrest

  MAUDE report 14781621 ↗
• DeathApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH A RARE BLOOD CLOTTING DISORDER PRESENTED TO THE EMERGENCY DEPARTMENT IN UNSTABLE CONDITION WITH CLOTTING ABOVE HIS EXISTING INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT ALSO HAD BILATERAL DEEP VEIN THROMBOSIS (DVT) IN BOTH LEGS. THE IVC FILTER WAS PLACED 9 DAYS PRIOR AND THE PATIENT UNDERWENT SPINAL SURGERY 5 DAYS PRIOR. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN DID NOT SHOW A PULMONARY EMBOLISM. ANTICOAGULANT MEDICATION HAD BEEN DISCONTINUED SINCE THE TIME OF IVC FILTER PLACEMENT AND WAS NOT REINITIATED. THE TREATMENT PLAN WAS TO USE THE INARI FLOWTRIEVER 20 (T20) TO ADDRESS CLOTTING ABOVE AND IN THE IVC FILTER AND THEN USE THE INARI CLOTTRIEVER TO ADDRESS THE DVTS IN THE LEGS. AN ECHOCARDIOGRAM WAS NOT PERFORMED PRIOR TO THE PROCEDURE. AN ACTIVATED CLOTTING TIME (ACT) TEST WAS RUN AND THE ADVISING NEUROSURGEON REQUESTED LIMITING ANTICOAGULANTS. THE PATIENT WAS INTUBATED AND PLACED ON VASOPRESSORS. A 22 FR GORE DRYSEAL SHEATH WAS PLACED IN THE NECK AND AN 8 FR SHEATH WAS PLACED IN THE LEFT POPLITEAL VEIN. TWO INTERVENTIONAL RADIOLOGISTS WERE PRESENT, THE PRIMARY PHYSICIAN WAS ASSIGNED TO TREAT THE IVC CLOT WITH THE T20 AND THE SECOND PHYSICIAN PROVI

  Patient problems: Bradycardia; Cardiac Arrest; Cardiogenic Shock; High Blood Pressure/ Hypertension; Low Oxygen Saturation

  MAUDE report 14115860 ↗
• DeathMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2022 WITH LEFT LEG PAIN AND SWELLING AND WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS (DVT) IN HER LEFT LEG. FOLLOWING AN INTERVENTIONAL RADIOLOGY CONSULTATION, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND INTRAVENOUS HEPARIN WAS ADMINISTERED. BASED ON NO CHANGES IN THE PATIENT'S SYMPTOMS, DVT SURGICAL INTERVENTION WAS SCHEDULED FOR (B)(6) 2022. PREOPERATIVE ULTRASOUND REVEALED SIGNIFICANT LEFT-SIDED ILIOFEMORAL DVT WITH SHORT EXTENSION INTO THE OSTIUM OF THE INFERIOR VENA CAVA (IVC). THE SURGICAL PLAN WAS TO OBTAIN BILATERAL POPLITEAL ACCESS AND DEPLOY INARI FLOWTRIEVER XL DISKS AT THE ATRIAL-CAVAL JUNCTION FOR EMBOLIC PROTECTION AND ENGAGE LEFT-SIDED THROMBUS WITH THE INARI CLOTTRIEVER (CT). AFTER PERFORMING A LEFT-SIDED VENOGRAM USING A 5FR VERT CATHETER, A RIGHT-SIDED VENOGRAM WAS PERFORMED WITH A SECOND 5FR VERT CATHETER WHICH DEMONSTRATED A SEVERELY STENOTIC FEMORAL VEIN WITH MULTIPLE MATURE COLLATERALS AND A NATIVE VESSEL LOOKED LIKE IT MAY BE TOO SMALL TO ACCOMMODATE THE 12FR CATHETER FOR THE XL DISK. SERIAL DILATION WAS EMPLOYED ON THE RIGHT SIDE TO UPSIZE FROM A 6FR SHEATH TO AN 11FR SHEATH AND

  Patient problems: Abdominal Pain; Cardiac Arrest; Low Oxygen Saturation; Respiratory Arrest; Tachycardia; Thromboembolism; Ventricular Fibrillation

  MAUDE report 13773324 ↗
• DeathDec 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A (B)(6) MALE PATIENT WAS TRANSFERRED FROM A NEARBY HOSPITAL AND SCHEDULED FOR A THROMBECTOMY TO ADDRESS A PREEXISTING BILATERAL DEEP VEIN THROMBOSIS (DVT) WITH A CLOTTED INFERIOR VENA CAVA (IVC) GREENFIELD FILTER. ON (B)(6) 2021, THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM (CT CATHETHER AND CT SHEATH) WAS USED TO TREAT THE DVT. THE PATIENT WAS PLACED IN THE SUPINE POSITION AND ADMINISTERED GENERAL ANESTHESIA AND HEPARIN. PRIOR TO CLOTTRIEVER USE, THE PATIENT UNDERWENT SUCTION THROMBECTOMY USING THE ANGIODYNAMICS ALPHAVAC DEVICE WITHIN THE IVC AND FILTER WHICH YIELDED LITTLE CLOT. A 7 FR FOGARTY EMBOLECTOMY CATHETER WAS SUBSEQUENTLY USED FOR AN ADDITIONAL THROMBECTOMY PERFORMED IN THE IVC; MULTIPLE PASSES YIELDED SIGNIFICANT CLOT REMOVAL. ULTRASOUND-GUIDED ACCESS WAS OBTAINED VIA BILATERAL POPLITEAL VEINS AND A 260 CM BENTSON WIRE WAS USED TO WIRE THE RIGHT POPLITEAL VEIN UP TO THE IVC FILTER. THIS WAS EXCHANGED FOR A 260 CM AMPLATZ GUIDEWIRE WHICH WAS THEN ADVANCED THROUGH A 12 FR JUGULAR SHEATH AT THE RIGHT JUGULAR VEIN. THE INARI CT SHEATH WAS THEN INSERTED INTO THE RIGHT POPLITEAL VEIN AND THE CT FUNNEL WAS IMAGED CONFIRMING PROPER OPENING. THE CT CATHETER WAS INSERTED THROU

  Patient problems: Cardiac Arrest; Extravasation; Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Pulmonary Embolism; Respiratory Arrest

  MAUDE report 13064500 ↗
• DeathNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE WHO HAD UNDERGONE A KNEE REPLACEMENT AND LUMBAR SURGERY YEARS AGO PRESENTED WITH RIGHT SIDED DEEP VEIN THROMBOSIS (DVT). THE PULMONARY EMBOLISM (PE) SCAN WAS NEGATIVE AND THE INFERIOR VENA CAVA WAS PRESUMED CLEAR PER THE PHYSICIAN. ON (B)(6) 2021, THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM (CT CATHETER AND CT SHEATH) WAS USED TO ATTEMPT TO TREAT THE DVT. AFTER DILATION, A 16 FR CLOTTRIEVER (CT) SHEATH WAS USED AND THE PATIENT WAS PLACED IN THE PRONE POSITION. THE PATIENT'S BASELINE VITAL SIGNS WERE AS FOLLOWS: BLOOD PRESSURE (BP) 123/83 MMHG, OXYGEN SATURATION (SPO2) 100% ON ROOM AIR, HEART RATE (HR) HIGH 80'S (BPM). THE FIRST PASS WAS PERFORMED WITH THE CT CATHETER AND YIELDED SIGNIFICANT CLOT, DURING WHICH TIME THE PATIENT REPORTED EXPERIENCING MILD PAIN. THE CT WAS CLEANED, RE-SHEATHED, AND INTRODUCED FOR A SECOND PASS. AS THE CT WAS PULLED THROUGH THE RIGHT INNOMINATE VEIN (RIV) THE PATIENT REPORTED SEVERE PAIN AND NAUSEA AND VOMITED. ZOFRAN WAS ADMINISTERED INTRAVENOUSLY AND THE PATIENT LOST CONSCIOUSNESS. ALL VITAL SIGNS REMAINED STABLE AND THE SECOND PASS ALSO YIELDED SIGNIFICANT CLOT. A THIRD PASS ALSO YIELDED (LESSER) CLOT. BLEED BACK WAS OBSERVED AT THE

  Patient problems: Cardiac Arrest; Embolism/Embolus; Intraoperative Pain; Loss of consciousness; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Respiratory Arrest

  MAUDE report 12837311 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) FEMALE WITH A HISTORY OF 13S PROTEIN DEFICIENCY PRESENTED TO THE HOSPITAL ON (B)(6) 2021 WITH SEVERE LOWER LEG EXTREMITY (LLE) SWELLING AND PAIN IN THE LEFT LEG. THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG; COMPUTED TOMOGRAPHY ANGIOGRAMS (CTAS) AND ULTRASOUND IMAGING REVEALED EXTENSIVE THROMBUS AND THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY. THE PATIENT ALSO HAD AN ASYMPTOMATIC SUBSEGMENTAL BILATERAL PULMONARY EMBOLISM (PE), BUT THERE WAS NO PLAN TO ADDRESS THIS SURGICALLY. ON THE MORNING OF (B)(6) 2021, THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM (CT CATHETER AND CT SHEATH) WAS USED TO ATTEMPT TO TREAT THE DVT. THE PATIENT WAS PLACED IN THE PRONE POSITION AND ACCESS WAS OBTAINED WITH A 5 FR TERUMO SHEATH. THE PHYSICIAN WIRED TO THE SUBCLAVIAN VEIN WITH A GLIDE ADVANTAGE GUIDEWIRE AND KUMPE CATHETER. THE TARGET VESSEL FOR THE CT FUNNEL WAS EXPANDED WITH AN EV3 6X4 MM BALLOON AND THE VESSEL WAS DILATED TO 16 FR. A 13 FR CT SHEATH WAS INSERTED WITHOUT ISSUE. THE CT CATHETER WAS INSERTED AND WHEN THE FIRST CLOT WAS RETRIEVED THE PATIENT REPORTED EXPERIENCING EXTREME PAIN. THE PHYSICIAN THEN DILATED THE LLE WITH AN EV3 10X40 MM BALLOON AND

  Patient problems: Cerebral Edema; Dyspnea; High Blood Pressure/ Hypertension; Intraoperative Pain; Loss of consciousness; Low Oxygen Saturation; Pulmonary Embolism; Stroke/CVA; Tachycardia

  MAUDE report 12752763 ↗
• MalfunctionJun 16, 2021Device Difficult to Setup or Prepare

  THIS PRODUCT IS USED IN A THROMBECTOMY PROCEDURE. IT IS NORMALLY INSERTED INTO THE BODY, BROUGHT OUT OF THE BODY, THROMBI/CLOTS ARE REMOVED FROM THE CATHETER, AND THE CATHETER IS REINSERTED AGAIN TO REPEAT THE PROCESS. THIS WAS INSERTED INTO THE PATIENT AND BROUGHT OUT OF THE PATIENT AND BEFORE IT WAS REINSERTED, THE CATHETER SHOULD BE RESHEATHED. THERE WAS DIFFICULTY IN RESHEATHING THE CATHETER SO IT WAS NOT ABLE TO BE REUSED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016549 ↗
• DeathApr 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AN (B)(6) YEAR-OLD MALE PATIENT WITH DIABETES AND RECENT PNEUMONIA PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2021 EXPERIENCING SHORTNESS OF BREATH FOR THE PAST 2-3 DAYS. THE PATIENT HAD SEVERE SEPSIS, HYPOXIA, HYPERTENSION, AND ELEVATED TROPONINS, AND HIS FAMILY STATED THAT THE PATIENT WAS "NOT LUCID" UPON ADMISSION. A CT SCAN REVEALED BILATERAL PULMONARY EMBOLISM (PE) THAT WAS CLASSIFIED AS HIGH-RISK SUBMASSIVE, WITH A RV/LV RATIO OF 1.2 AND CONCOMITANT DEEP VEIN THROMBOSIS (DVT) THAT DID NOT WARRANT INTERVENTION. ON (B)(6) 2021, THE INARI TRIEVER16 (T16) AND TRIEVER24 (T24) WERE USED TO ATTEMPT TO TREAT THE PE. THE PATIENT WAS PLACED ON A HEPARIN DRIP AT THE BEGINNING OF THE PROCEDURE. HIS HEART RATE WAS 84 BPM, BLOOD PRESSURE 113/66 MMHG, SPO2 98%, AND HEMOGLOBIN 13. HIS BASELINE ACT WAS 126, AND 5,000 UNITS OF HEPARIN WERE ADMINISTERED. AFTER ACCESS WAS GAINED, A SWAN-GANZ CATHETER WAS USED TO TAKE A PULMONARY ARTERY (PA) PRESSURE MEASUREMENT OF 66/26/40, INDICATING THE PATIENT HAD SEVERE PULMONARY HYPERTENSION. IMAGING CONFIRMED THE PRESENCE OF CLOT IN THE TRUNCUS ANTERIOR AND ON THE RIGHT. A 24F GORE DRYSEAL SHEATH WAS INSERTED INTO THE RIGHT COMMON FEMORAL VEIN, AND A

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Loss of consciousness; Low Blood Pressure/ Hypotension; Respiratory Arrest

  MAUDE report 11682927 ↗
• InjuryMar 9, 2021Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH PANCREATIC CANCER PRESENTED TO THE HOSPITAL WITH PHLEGMASIA, COMPLAINING OF LEG PAIN. A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED EXTENSIVE THROMBOSIS EXTENDING FROM THE RIGHT TIBIAL VEIN TO THE COMMON ILIAC VEIN. ON (B)(6) 2021, THE INARI MEDICAL CLOTTRIEVER (CT) SYSTEM, COMPRISED OF THE CT CATHETER AND CT SHEATH (13F), WAS USED TO ATTEMPT TO TREAT THE DEEP VEIN THROMBOSIS (DVT). ACCESS WAS GAINED VIA THE RIGHT POPLITEAL VEIN WITH A 5F SHEATH. A TERUMO GUIDEWIRE WAS ADVANCED TO THE SUBCLAVIAN VEIN ALONG WITH A 120 CM CATHETER. THE GLIDEWIRE WAS THEN EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE, AND THE 5F SHEATH WAS UPSIZED TO AN 8F SHEATH. THE VESSEL UP TO THE EXTERNAL ILIAC VEIN WAS BALLOONED WITH AN 8 MM BALLOON, AND ULTRASOUND WAS USED TO CONFIRM THE AMOUNT AND LOCATION OF THE CLOT. THE CT SHEATH WAS INSERTED, AND 6 PASSES WERE PERFORMED WITH THE CT CATHETER, COMPLETELY CLEARING THE COMMON ILIAC, EXTERNAL ILIAC, AND COMMON FEMORAL VEINS OF THROMBUS. THE POPLITEAL VEIN WAS THEN BALLOONED WITH THE 8 MM BALLOON, AND ONE CT PASS RETRIEVED A SMALL AMOUNT OF CLOT. A SECOND PASS WAS CONDUCTED, BUT THE CT CATHETER COULD NOT BE REMOVE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11447746 ↗
• DeathJan 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY, WHO SHARED THAT THE PATIENT DIED ON (B)(6) 2020.

  Patient problems: Cardiac Arrest; Loss of consciousness; Low Blood Pressure/ Hypotension; Pulmonary Embolism; Respiratory Arrest

  MAUDE report 11219563 ↗
• InjurySep 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A (B)(6)-YEAR-OLD FEMALE PATIENT (NON-SMOKER) WITH A HISTORY OF RECENT NUVARING CONTRACEPTIVE USAGE AND NO FAMILY HISTORY OF PULMONARY EMBOLISM OR DEEP VEIN THROMBOSIS (DVT) PRESENTED TO THE HOSPITAL WITH SUSPECTED MAY-THURNER SYNDROME DVT. ON (B)(6) 2020, THE INARI MEDICAL CLOTTRIEVER (CT) SYSTEM, COMPRISED OF THE CT CATHETER AND CT SHEATH, WAS USED TO ATTEMPT TO TREAT THE DVT. THE PATIENT'S VITAL SIGNS WERE STABLE PRIOR TO THE PROCEDURE. WITH THE PATIENT IN THE SUPINE POSITION, ULTRASOUND WAS USED TO GUIDE ACCESS VIA THE RIGHT POPLITEAL VEIN. THE ACCESS SITE WAS DILATED TO ACCOMMODATE THE CT SHEATH, AND A TERUMO GLIDE ADVANTAGE GUIDEWIRE WAS ADVANCED TO THE SUPERIOR VENA CAVA. THE CT CATHETER WAS INSERTED, AND ONE PASS WAS PERFORMED WITH THE PHYSICIAN COLLAPSING THE CATHETER CORING ELEMENT AT THE SUSPECTED MAY-THURNER SEGMENT. A MODERATE AMOUNT OF CLOT WAS RETRIEVED FROM THE COLLECTION BAG. THE PATIENT REPORTED EXPERIENCING PAIN DURING THIS PASS, SO THE PHYSICIAN ORDERED 6 MG OF VERSED TO BE ADMINISTERED IN ADDITION TO THE 50 MG OF DEMEROL THAT WAS GIVEN AT THE BEGINNING OF THE CASE. AS THE DEVICE WAS PREPARED FOR ANOTHER PASS, THE PATIENT BECAME HYPOTENSIVE, SUDDENLY DECREASING

  Patient problems: Cardiopulmonary Arrest; Heart Failure; Low Blood Pressure/ Hypotension; Pulmonary Embolism

  MAUDE report 10496011 ↗
• InjuryAug 19, 2020Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL WITH BILATERAL THROMBUS FROM THE RENAL VEINS TO THE COMMON FEMORAL VEINS. ON (B)(6) 2020, THE INARI MEDICAL CLOTTRIEVER (CT) SYSTEM, COMPRISED OF THE CT CATHETER AND CT SHEATH, AS WELL AS THE TRIEVER20 (T20), WERE USED TO ATTEMPT TO TREAT THE PATIENT'S DEEP VEIN THROMBOSIS. THE PHYSICIAN BEGAN THE CASE BY USING THE T20 TO ASPIRATE IN THE RIGHT EXTERNAL ILIAC VEIN, BUT LITTLE CLOT WAS RETRIEVED. SUSPECTING THAT THE CLOT WAS MORE CHRONIC THAN EXPECTED, THE PHYSICIAN DECIDED TO REMOVE THE T20 AND SWITCH TO THE CT SYSTEM AND PLACED THE SHEATH AND CATHETER IN THE LEFT COMMON ILIAC VEIN. AS THE CORING ELEMENT OF THE DEVICE WAS RETRACTED, FLUOROSCOPY REVEALED THAT A LARGE CLOT HAD BEEN CAPTURED IN THE CT CATHETER'S COLLECTION BAG. AFTER UNSUCCESSFUL ATTEMPTS TO REMOVE THE SHEATH AND CATHETER IN TANDEM, ONLY THE SHEATH WAS ABLE TO BE REMOVED. A VENOUS CUTDOWN WAS PERFORMED IN ORDER TO REMOVE THE CATHETER SAFELY FROM THE VESSEL. THE CASE WAS THEN COMPLETED WITHOUT FURTHER INCIDENT. THE PATHOLOGY REPORT SUBSEQUENTLY CONFIRMED THAT THE CLOT WAS CHRONIC. THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT ISSUE AND WAS DISCHARGED FROM THE

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10428033 ↗
• InjuryJul 29, 2020Entrapment of Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Entrapment of Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL WITH CHRONIC, 6-MONTH-OLD CLOT IN THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2020, THE INARI MEDICAL CLOTTRIEVER (CT) SYSTEM, COMPRISED OF THE CT CATHETER AND CT SHEATH, WAS USED TO ATTEMPT TO TREAT THE PATIENT'S DEEP VEIN THROMBOSIS. ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL VEIN. STARTING AT THE JUNCTION OF THE IVC AND RIGHT ATRIUM, THE PHYSICIAN SLOWLY WITHDREW THE CT CATHETER CORING ELEMENT AT 1 MM/SECOND TOWARD THE ACCESS SITE AND WAS ABLE TO DOCK THE CORING ELEMENT AND COLLECTION BAG AT THE CT SHEATH FUNNEL. AFTER COLLAPSING THE COLLECTION BAG, THE PHYSICIAN ATTEMPTED TO PULL THE CORING ELEMENT THROUGH THE SHEATH, BUT WAS UNABLE TO DO SO, EVEN AFTER USING EXCESSIVE FORCE. THE CT SHEATH WAS REMOVED FROM THE PATIENT, AND THE PHYSICIAN RESUMED ATTEMPTS TO REMOVE THE CT CATHETER. AFTER UNSUCCESSFUL EFFORTS TO WITHDRAW THE CATHETER, A VENOUS CUTDOWN WAS PERFORMED AND THE CORING ELEMENT WAS MANUALLY COMPRESSED TO SAFELY REMOVE THE CATHETER FROM THE VESSEL. UPON EXAMINATION OF THE CT CATHETER, A LARGE, 12-INCH PIECE OF CHRONIC CLOT WAS FOUND IN THE CORING ELEMENT. PRESSURE WAS HELD AT THE ACCESS SITE WHILE A SECOND INARI C

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 10341048 ↗
• InjuryJul 8, 2020Entrapment of Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Entrapment of Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  A (B)(6)-YEAR-OLD MORBIDLY OBESE FEMALE PATIENT WITH A HISTORY OF SMOKING PRESENTED TO THE EMERGENCY DEPARTMENT IN EARLY (B)(6) 2020 WITH LEG PAIN. A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED EXTENSIVE RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) AND SUBMISSIVE PULMONARY EMBOLISM (PE). PER THE HOSPITAL'S COVID-19 PROTOCOL AT THAT TIME, THE PLAN WAS TO TREAT THE DVT AND PE MEDICALLY (ELIQUIS PRESCRIBED) AND THE PATIENT WAS DISCHARGED. IN EARLY JUNE, THE PATIENT WAS SCHEDULED FOR SURGERY TO ADDRESS THE PREEXISTING DVT, WHICH WAS NOW A ONE-MONTH-OLD CHRONIC CLOT; HOWEVER, THERE WAS NO PLAN TO TREAT THE PE SURGICALLY. ON (B)(6) 2020, THE INARI MEDICAL CLOTTRIEVER (CT) SYSTEM, COMPRISED OF THE CT SHEATH AND CT CATHETER, WAS USED TO TREAT THE DVT. WITH THE PATIENT IN THE PRONE POSITION, ACCESS WAS GAINED VIA THE RIGHT POPLITEAL VEIN FOR VENOGRAMS, WHICH CONFIRMED THE DVT AND A CLEAR INFERIOR VENA CAVA. A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED TO THE INTERNAL JUGULAR VEIN. INTRAVASCULAR ULTRASOUND WAS THEN USED TO CONFIRM THE GUIDEWIRE WAS IN THE DESIRED VESSEL WITH A DIAMETER GREATER THAN 6MM. THE VESSEL WAS THEN DILATED UP TO 14 F, AND THE CT SHEATH WAS INSERTED A

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 10248827 ↗
• InjuryMay 28, 2020Use of Device Problem; Use of Device Problem

  A (B)(6) YEAR-OLD MALE PATIENT ON ANTICOAGULATION MEDICINE WITH NO KNOWN HISTORY OF DEEP VEIN THROMBOSIS (DVT) PRESENTED TO THE HOSPITAL WITH SWELLING IN HIS LEFT ARM AND FINGER NUMBNESS, WHICH WERE FOUND TO BE DUE TO THORACIC OUTLET SYNDROME. A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED THROMBUS IN THE SUBCLAVIAN AND LEFT AXILLARY VESSELS; THE SUBCLAVIAN VEIN WAS ALSO NOTED TO HAVE NOTICEABLE STRICTURE. ON (B)(6) 2020, THE INARI MEDICAL CLOTTRIEVER WAS USED TO TREAT THE THROMBUS. USING ULTRASOUND, BRACHIAL ACCESS WAS GAINED USING A 5 FR MICROPUNCTURE, AFTER WHICH A TERUMO GLIDEWIRE WAS ADVANCED TO THE INFERIOR VENA CAVA TO PERFORM THE VENOGRAM. USING THE VENOGRAM, THE ATTENDING PHYSICIAN DETERMINED THAT THE VESSEL OF INITIAL ACCESS WAS TOO SMALL, AND THE DECISION WAS MADE TO ACCESS A LARGER VESSEL. A NEW VESSEL THAT APPEARED TO BE OF A MORE APPROPRIATE SIZE WAS IDENTIFIED AND ACCESSED, THE GLIDEWIRE WAS EXCHANGED FOR A 260 CM BOSTON SCIENTIFIC AMPLATZ GUIDEWIRE, AND THE ACCESS SITE WAS DILATED WITH A 14 FR COOK COONS DILATOR. THE ACTUAL DIMENSIONS OF THE NEW VESSEL WERE NOT CONFIRMED WITH ULTRASOUND. THE CLOTTRIEVER SHEATH WAS INSERTED THREE-QUARTERS OF THE WAY BEFORE THE PHYSICIAN FE

  Patient problems: Perforation of Vessels

  MAUDE report 10097542 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR-OLD FEMALE PATIENT WITH NO PRIOR HISTORY OF CLOTTING AND A RECENT HISTORY OF DYSPNEA PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH EXTENSIVE DEEP VEIN THROMBOSIS (DVT) IN THE LOWER LEFT EXTREMITY. DUE TO CAPACITY CONSTRAINTS, THE PATIENT WAS TRANSFERRED TO A NEARBY HOSPITAL FOR TREATMENT AND PLACED ON HEPARIN. THE PATIENT TESTED NEGATIVE FOR COVID-19, HOWEVER, IT WAS THOUGHT THAT SHE MAY HAVE HAD THE VIRUS BEFORE OVERCOMING IT, AND THAT IT MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE DVT. ON (B)(6) 2020, INARI MEDICAL'S CLOTTRIEVER WAS USED TO TREAT THE DVT. ALTHOUGH THE PATIENT'S VEINS MEASURED SLIGHTLY SMALLER THAN AVERAGE ADULT VEINS, A RISK-BASED DECISION WAS MADE THAT THE CLOTTRIEVER DEVICE COULD BE SAFELY USED. ULTRASOUND WAS USED TO GAIN ACCESS IN THE LEFT POPLITEAL VEIN USING A 5 FR MICROPUNCTURE, WHICH WAS THEN EXCHANGED FOR A 7 FR ACCESS SHEATH. AN AMPLATZ SUPER STIFF GUIDEWIRE (260/7 CM) WAS THEN USED TO GUIDE AN ANGIOGRAPHIC FLUSH CATHETER (COOK MEDICAL), WHICH WAS SUBSEQUENTLY REMOVED FOR A VENOGRAM. THE VENOGRAM CONFIRMED PHLEGMASIA AND CLOT FROM THE LEFT POPLITEAL VEIN TO THE LEFT COMMON ILIAC VEIN, WITH NO CLOT PRESENT IN THE INFERIOR

  Patient problems: Cardiopulmonary Arrest; Pulmonary Embolism

  MAUDE report 10068219 ↗
• DeathApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD OBESE FEMALE PATIENT WITH A HISTORY OF A BILATERAL MASTECTOMY (ONE WEEK PRIOR) AND RECENT NEUROLOGICAL CHANGES WAS DIAGNOSED WITH ACUTE DEEP VEIN THROMBOSIS (DVT). VENOGRAMS REVEALED CLOT BURDEN IN THE LEFT ILIAC VEINS AND LEFT FEMORAL VEIN. A COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY SCAN FROM EARLIER IN THE WEEK ALSO INDICATED THE PRESENCE OF A PULMONARY EMBOLISM (PE). ON (B)(6) 2020, THE INARI CLOTTRIEVER WAS USED TO TREAT THE DVT. AFTER THE PATIENT WAS INTUBATED, ACCESS WAS GAINED VIA THE LEFT POPLITEAL VEIN. THREE PASSES WITH THE DEVICE WERE PERFORMED WITH EACH PASS YIELDING ACUTE, SMALL CLOT PIECES. AFTER THE THIRD PASS, THE CLOTTRIEVER CATHETER WAS REMOVED FROM THE PATIENT; AS IT WAS BEING CLEANED, THE PATIENT'S VITAL SIGNS BECAME UNSTABLE AND BLOOD PRESSURE DECREASED. THE DECOMPENSATION WAS DUE TO A SUSPECTED PE (LIKELY ATTRIBUTED TO INADVERTENT DISLODGEMENT OF THE DVT CLOT). THE PATIENT WAS REPOSITIONED FROM PRONE TO SUPINE, AND A CARDIOLOGIST WAS CALLED IN FOR ASSISTANCE. THE PATIENT CONTINUED TO DECOMPENSATE AND ARRESTED. CHEST COMPRESSIONS WERE PERFORMED FOR 15-20 MINUTES UNTIL THE PATIENT WAS STABLE ENOUGH TO USE THE INARI TRIEVER20 TO ATTEMPT TO REMOVE CL

  Patient problems: Cardiopulmonary Arrest; Death; Pulmonary Embolism

  MAUDE report 9936087 ↗
• InjuryJan 15, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A (B)(6)-YEAR-OLD FEMALE PATIENT IN HER SECOND TRIMESTER OF PREGNANCY PRESENTING WITH A SWOLLEN LEFT LEG WAS DIAGNOSED WITH A LOWER LEFT EXTREMITY DEEP VEIN THROMBOSIS (DVT) THAT EXTENDED FROM THE COMMON ILIAC VEIN TO THE POPLITEAL VEIN. THE TREATING PHYSICIAN SUSPECTED MAY-TURNER SYNDROME EXACERBATED BY PREGNANCY. THE PATIENT WAS A MULTIGRAVIDA AT 14 WEEKS' GESTATION WITH A HISTORY OF A DVT IN HER FIRST PREGNANCY AND LOVENOX AND HAD BEEN PRESCRIBED DAILY. ON (B)(6) 2019, THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM WAS USED DURING A PERIPHERAL THROMBECTOMY TREATMENT. THE PATIENT WAS POSITIONED SUPINE AND THE CLOTTRIEVER SHEATH WAS PLACED IN THE LEFT POPLITEAL VEIN. WITH CONCERN FOR PREGNANCY THE PLAN WAS TO MINIMIZE CONTRAST VOLUME AND FLUOROSCOPY. TO MINIMIZE CONTRAST USAGE, INTRAVASCULAR ULTRASOUND (IVUS) WAS UTILIZED TO DETERMINE THE CLOT LOCATION AND VESSEL PATENCY. TO MINIMIZE FLUOROSCOPY, IT WAS USED ONLY BRIEFLY ON THE FIRST CLOTTRIEVER CATHETER PASS (WITH RELATION TO THE CLOTTRIEVER SHEATH) AND THE SECURED STERILE DRAPE WAS MARKED TO SERVE AS A LANDMARK FOR SUBSEQUENT PASSES. NO THROMBOLYTIC AGENTS WERE ADMINISTERED. DURING THE 3RD OR 4TH PASS, WHILE THE CLOTTRIEVER CATHETER

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 9594222 ↗