ClotTriever BOLD Catheter 42-102 (UDI 00850291007314)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00850291007314), received between Oct 25, 2022 and Nov 20, 2025 — classified as 6 deaths, 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• DeathNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 36-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A HISTORY OF PULMONARY EMBOLISM (PE) AND HAD A PREEXISTING FILTER IN HIS INFERIOR VENA CAVA (IVC). THE PATIENT UNDERWENT A PE THROMBECTOMY IN (B)(6) 2025. THE PATIENT HAD BEEN INCARCERATED THE MONTH BEFORE THE DVT THROMBECTOMY, WHICH LEAD TO THE PATIENT DISCONTINUING HIS ELIQUIS PRESCRIPTION. THE PATIENT SUBSEQUENTLY DEVELOPED CLOT IN HIS IVC FILTER THAT EXTENDED TO HIS BILATERAL VEINS BELOW. THE PATIENT IVC FILTER WAS REMOVED VIA THE INTERNAL JUGULAR VEIN (IJ) AND WAS THEN POSITIONED SUPINE FOR THE REMAINING DVT THROMBECTOMY. FOUR PASSES WERE COMPLETED ON THE LEFT AND SIX ON THE RIGHT USING THE CLOTTRIEVER BOLD CATHETER (CT BOLD). AT THE COMPLETION OF THE PROCEDURE, WHILE THE ACCESS SITE WAS BEING CLOSED, THE PATIENT BEGAN TO DECOMPENSATE. A CODE WAS CALLED, AND THE CRITICAL RESPONSE TEAM ATTEMPTED TO RESUSCITATE THE PATIENT FOR EIGHTY MINUTES; HOWEVER, THE PATIENT ULTIMATELY EXPIRED.

  Patient problems: Pulmonary Embolism

  MAUDE report 23609440 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 84-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY USING THE INARI CLOTTRIEVER BOLD SYSTEM TO ADDRESS HER UPPER EXTREMITY DEEP VEIN THROMBOSIS. AFTER WIRE POSITIONING WAS OBTAINED, THE 13 FR CLOTTRIEVER SHEATH WAS PLACED AND THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED INTO PLACE. A PASS WAS PERFORMED WHICH REMOVED CHRONIC CLOT. AN ANGIOGRAM WAS PERFORMED AND EXTRAVASATION WAS DISCOVERED NEAR THE FUNNEL. AN ANGIOPLASTY WAS PERFORMED BY BALLOONING. AFTER 20 MINUTES, THE PHYSICIAN WAS SATISFIED THAT THE VESSEL DID NOT NEED FURTHER TREATMENT OR STENTING. THE PHYSICIAN ALSO IDENTIFIED A PSEUDO ANEURYSM; HOWEVER, NO ADDITIONAL TREATMENT WAS NECESSARY. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Vascular Dissection

  MAUDE report 22056636 ↗
• DeathMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY WITH INARI DEVICES TO ADDRESS HER DEEP VEIN THROMBOSIS. THE PATIENT HAD CLOT RANGING FROM THE FEMORAL VEIN INTO THE INFERIOR VENA CAVA (IVC). THE PLAN WAS TO PERFORM THE PROCEDURE WITHOUT EMBOLIC PROTECTION. WIRE POSITIONING WAS OBTAINED WITHOUT ISSUE AND A CLOTTRIEVER BOLD CATHETER WAS ADVANCED INTO PLACE AFTER A 13 FR CLOTTRIEVER SHEATH WAS INSERTED. 3 PASSES WERE PERFORMED THEN THE VITALS MACHINE STOPPED PICKING UP THE PATIENT'S OXYGEN SATURATION. THE PATIENT THEN BECAME TACHYCARDIC AND BEGAN HAVING PREMATURE VENTRICULAR CONTRACTIONS. THE PROCEDURE WAS ABORTED IN ATTEMPTS TO STABILIZE THE PATIENT. A RAPID RESPONSE WAS INITIATED, AND A CODE WAS CALLED SOON AFTER. CARDIOPULMONARY RESUSCITATION WAS CONDUCTED FOR 45 MINUTES BEFORE THE PATIENT'S FAMILY DECIDED TO DISCONTINUE IT. THE PATIENT EXPIRED. FOLLOW-UP INFORMATION REVEALED THAT THE PATIENT'S INITIAL COMPUTED TOMOGRAPHY SCAN SHOWED A SMALL DISTAL PULMONARY EMBOLISM, THE PHYSICIAN DECIDED NOT TO INTERVENE. THE PHYSICIAN ALSO INDICATED THAT THE PATIENT'S DETERIORATION COULD POTENTIALLY BE THE RESULT OF SEDATION AND/OR CLOT BEING SENT TO THE PULMONARY ARTERIES.

  Patient problems: Pulmonary Embolism

  MAUDE report 22037973 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 43-YEAR-OLD OBESE FEMALE WAS DIAGNOSED WITH LOWER LEFT EXTREMITY DEEP VEIN THROMBOSIS (DVT). A THROMBECTOMY WAS SCHEDULED WITH THE INARI CLOTTRIEVER SYSTEM. THE PATIENT WAS PLACED PRONE FOR THE PROCEDURE AND ACCESS WAS OBTAINED. 5K OF HEPARIN WAS ALSO ADMINISTERED. THE PHYSICIAN ALTERNATED PERFORMING PASSES WITH THE CLOTTRIEVER XL CATHETER (CTXL) AND THE CLOTTRIEVER BOLD CATHETER (CT BOLD). THIS REMOVED A SIGNIFICANT AMOUNT OF CHRONIC CLOT. IMAGING WAS PERFORMED THROUGH THE SHEATH WHICH REVEALED PROCEDURAL CLOT. THE CT BOLD WAS REINSERTED TO REMOVE CLOT, BUT THE CLOT APPEARED TO HAVE BEEN PUSHED FORWARD UPON THE REINSERTION. THE PATIENT BECAME AGITATED AND COMPLAINED OF SHORTNESS OF BREATH. THE PATIENT BECAME UNRESPONSIVE AND WENT INTO PULSELESS ELECTRICAL ACTIVITY. A CODE WAS CALLED, AND RESUSCITATION EFFORTS BEGAN. 45 MINUTES OF CARDIOPULMONARY RESUSCITATION WAS PERFORMED WITH THE ADMINISTRATION OF EPINEPHRINE, SODIUM BICARBONATE, AND LIDOCAINE. THE PATIENT THEN STABILIZED. A COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED LATER WHICH REVEALED A SMALL AMOUNT OF SUB-SEGMENTAL CLOT REMAINED. THE PATIENT WAS LAST REPORTED TO BE ALIVE AND RESPONSIVE.

  Patient problems: Pulmonary Embolism

  MAUDE report 21118747 ↗
• MalfunctionJan 2, 2025Break; Break

  ON DECEMBER 4TH 2024, (B)(6) MEDICAL RECEIVED A COPY OF A MEDSUN REPORT (B)(4) ALLEGING "THE COPPER CORE OF THE THROMBECTOMY CATHETER BROKE OFF AFTER SEVERAL USES OUTSIDE THE PATIENT AS THE CATHETER WAS BEING CLEANED/FLUSHED. THERE WAS NO HARM TO THE PATIENT"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21062512 ↗
• InjuryAug 7, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 67-YEAR-OLD FEMALE WITH DEEP VEIN THROMBOSIS WAS TAKEN IN BY INTERVENTIONAL RADIOLOGY. INFERIOR VENA CAVA (IVC) THROMBUS WAS OBSERVED ON THE COMPUTED TOMOGRAPHY SCAN. THE PHYSICIAN WAS CONFIDENT THAT CLOT WAS ISOLATED TO THE COMMON ILIAC VEIN WITH POSSIBLE THROMBUS AT THE CONFLUENCE. THE PATIENT WAS INITIALLY PLACED ON ANTICOAGULATION, BUT AFTER A WEEK, THE DECISION WAS MADE TO PERFORM A MECHANICAL THROMBECTOMY. A VENOGRAM WAS PERFORMED CONFIRMING THE CLOT LOCATION, IT ALSO REVEALED A SMALL PULMONARY EMBOLISM. RIGHT VENTRICLE DILATION MAY HAVE BEEN PRESENT, BUT THE CLOT WAS TOO DISTAL TO WARRANT INTERVENTION. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED PRE-PROCEDURE TO FURTHER CONFIRM THE CLOT LOCATION AND EXTENT. THE PHYSICIAN PERFORMED 2 PASSES WITH THE CLOTTRIEVER BOLD CATHETER (CT BOLD). THIS REMOVED SMALL AMOUNTS OF ACUTE CLOT AND THE PHYSICIAN DECIDED TO PERFORM IVUS. FREE-FLOATING THROMBUS WAS BRIEFLY OBSERVED BUT DUE TO ENVIRONMENTAL REASONS, IT WAS DIFFICULT TO REPEAT OR PERFORM SYSTEMATIC IVUS UTILIZATION. 2 MORE PASSES WERE COMPLETE WITH MINIMAL CLOT REMOVED. VENOGRAPHY WAS PERFORMED WHICH REVEALED THAT THEY MAY HAVE MOBILIZED THROMBUS INTO AND THROUGH THE IVC AL

  Patient problems: Pulmonary Embolism

  MAUDE report 19933725 ↗
• MalfunctionJul 24, 2024Entrapment of Device; Retraction Problem; Material Separation; Entrapment of Device; Retraction Problem; Material Separation

  ON (B)(6) 2024, A 36-YEAR-OLD MALE WITH LOWER LEFT EXTREMITY DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A STENT IN THE LEFT COMMON ILIAC VEIN AND PRESENTED WITH SIGNIFICANT SWELLING IN HIS LEFT LEG. THE CLOT AGE WAS ESTIMATED AT 90 DAYS. DURING DVT THROMBECTOMY, A PROTRIEVE SHEATH WAS PLACED IN THE PATIENT'S RIGHT INTERNAL JUGULAR AND THE CLOTTRIEVER SHEATH, 16 FR (CT SHEATH) WAS PLACED IN THE LEFT POPLITEAL VEIN AS THE PRIMARY ACCESS SITE. THE CLOTTRIEVER BOLD (CT BOLD) COMPLETED THREE PASSES BELOW THE PATIENT'S STENT, WITH THE TIP OF THE CT BOLD BELOW THE PROXIMAL END OF THE STENT. THE REVCORE CATHETER COMPLETED FOUR PASSES WITHIN THE STENT. ONE ADDITIONAL PASS WAS COMPLETED WITH THE CT BOLD AND THE DEVICE WAS WALKED DOWN EASILY UNTIL THE CORING ELEMENT WAS HALFWAY DOWN THE FEMORAL VEIN, AT WHICH POINT THE PHYSICIAN EXPERIENCED SIGNIFICANT RESISTANCE TO RETRACT THE CT BOLD CATHETER. MULTIPLE ATTEMPTS WERE MADE TO PULL THE DEVICE BACK, BUT SIGNIFICANT RESISTANCE CONTINUED TO BE A BARRIER. THE CT BOLD WAS EVENTUALLY ABLE TO BE RETRACTED TO THE FUNNEL OF THE CT SHEATH AFTER THE PHYSICIAN ADVANCED THE GRAY OUTER LUMEN OVER THE CORING EL

  Patient problems: Device Embedded In Tissue or Plaque; Hematoma; Vascular Dissection

  MAUDE report 19822610 ↗
• MalfunctionJun 26, 2024

  DURING A LEFT LOWER EXTREMITY (LLE) THROMBECTOMY STENTING, THE LINE WOULD NOT RETRACT BACK UP THRU THE PURPLE LINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19613500 ↗
• DeathMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 81-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH LEFT LEG PAIN AND SWELLING BUT WAS DISCHARGED AFTER A VENOUS DUPLEX WAS INCONCLUSIVE FOR DEEP VEIN THROMBOSIS (DVT). THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT 2 DAYS LATER DUE TO INCREASING LEG PAIN, SWELLING, AND SKIN COLOR CHANGES. ANOTHER VENOUS DUPLEX WAS PERFORMED WHICH REVEALED ILIOFEMORAL DVT IN THE LOWER LEFT EXTREMITY (LLE). THE PATIENT WAS GIVEN INTRAVENOUS HEPARIN AND A DVT THROMBECTOMY WAS SCHEDULED FOR THE NEXT MORNING. THE CLOT AGE WAS ESTIMATED AT 5 DAYS. PRIOR TO THE PROCEDURE, THE PATIENT RECEIVED A BLOOD TRANSFUSION FOR ANEMIA (UNKNOWN ETIOLOGY) UNDER CONSCIOUS SEDATION (VERSED 1 MG AND FENTANYL 25 MCG). A VENOGRAM REVEALED AN OPEN LEFT POPLITEAL VEIN WITH OCCLUSIVE CLOT STARTING IN THE MIDDLE FEMORAL VEIN. WIRE POSITIONING WAS OBTAINED AND THE INARI CLOTTRIEVER BOLD CATHETER WAS USED TO PERFORM A SINGLE PASS WHICH YIELDED ACUTE/SUB-ACUTE CLOT. A SECOND PASS WAS PERFORMED, AND AN ADDITIONAL 25 MCG OF FENTANYL WAS ADMINISTERED AFTER THE PATIENT REPORTED FEELING THE CATHETER PASS. BEFORE THE THIRD PASS WAS PERFORMED, THE PATIENT BEGAN TO DECOMPENSATE. OPIOID REVERSAL DRUGS WERE CALLED FO

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

  MAUDE report 19244278 ↗
• MalfunctionApr 11, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  A 42-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CANCER WAS DIAGNOSED WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) IN THE IVC SUPRARENAL AND LEFT ILIAC VEINS. THE PATIENT WAS SCHEDULED FOR THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM ON (B)(6) 2024. THE CLOT AGE WAS ESTIMATED AT 5 DAYS. DURING THROMBECTOMY, NO CLOT WAS REMOVED ON THE FIRST PASS USING THE CLOTTRIEVER BOLD CATHETER (CT BOLD). DURING THE SECOND PASS, THE CT BOLD BECAME CAUGHT IN A COMPRESSED AREA AND THE PHYSICIAN PULLED FORCEFULLY ON THE DEVICE IN AN ATTEMPT TO DISENGAGE THE CT BOLD. THE DEVICE WAS THEN SEPARATED INTO TWO PIECES BETWEEN THE CORING ELEMENT AND CATHETER. THE CORING ELEMENT AND BASKET REMAINED IN THE VASCULATURE WHEN THE CATHETER WAS REMOVED. THE CORING ELEMENT AND BASKET WERE REMOVED WITHOUT INCIDENT BY ACCESSING THE INTERNAL JUGULAR VEIN AND USING A PROTRIEVE SHEATH AND SNARING THE CLOTTRIEVER. THE SURGEON ELECTED TO DISCONTINUE THE THROMBECTOMY AND THE WOUND WAS CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085669 ↗
• InjuryMar 16, 2024Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress

  A 34-YEAR-OLD FEMALE PATIENT WAS HOSPITALIZED AFTER BEING INVOLVED IN A MAJOR MOTOR VEHICLE ACCIDENT AND SUSTAINING MULTIPLE SERIOUS INJURIES INCLUDING SEVERE INTRACRANIAL HEMORRHAGE, FRACTURED PELVIS, FRACTURED SPINE, AND OTHER TRAUMA. AFTER TREATING THE BRAIN BLEED AND PELVIS, INTERVENTIONAL RADIOLOGY INSERTED AN INFERIOR VENA CAVA (IVC) FILTER BECAUSE THE PATIENT WAS NOT A CANDIDATE FOR TREATMENT WITH HEPARIN TREATMENT. ONE WEEK LATER, THE PATIENT'S IVC WAS COMPLETELY OCCLUDED WITH BILATERAL DEEP VEIN THROMBOSIS (DVT) EXTENDING TO THE POPLITEAL VEINS. THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2024 WITH THE INARI FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM. THE CLOT AGE WAS ESTIMATED AT 7 DAYS. THE TRIEVER20 (T20) WAS DEPLOYED AND MULTIPLE ASPIRATIONS WERE PERFORMED IN THE IVC EXTENDING DOWN INTO THE LEFT ILIAC VEINS. THE PHYSICIAN REMOVED THE T20 AND DEPLOYED THE CLOTTRIEVER BOLD AND PERFORMED FOUR SUCCESSFUL PASSES. THEY WERE UNABLE TO REACH BEYOND THE FEMUR SO THE TRIEVER16 CURVE (T16C) WAS USED TO REMOVE ADDITIONAL CLOT PRESENT DISTALLY. HOWEVER, THE PHYSICIAN WAS UNABLE TO REACH CLOT REMAINING IN THE POPLITEAL AREA AND ADDITIONAL CLOT WAS OBSERVED IN THE IVC. TO ADD

  Patient problems: High Blood Pressure/ Hypertension; Tachycardia; Thromboembolism

  MAUDE report 18918989 ↗
• InjuryMar 1, 2024Entrapment of Device; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component

  A MALE PATIENT WITH DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LOWER EXTREMITY UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM ON (B)(6)2024. THE CLOT AGE WAS ESTIMATED AT 2 DAYS. AFTER THE GUIDEWIRE WAS PLACED, THE CLOTTRIEVER 13FR SHEATH (CT SHEATH) AND CLOTTRIEVER BOLD CATHETER (CT BOLD) WERE ADVANCED INTO POSITION. SIX PASSES WERE PERFORMED WHICH YIELDED SMALL AMOUNTS OF CLOT. A VENOGRAM REVEALED MODERATE CLOT CLEARANCE AND THE PHYSICIAN PLANNED TO PERFORM 2-3 MORE PASSES BEFORE ENDING THE CASE. HOWEVER, THE PHYSICIAN EXPERIENCED EXTREME RESISTANCE WHEN RETRACTING THE CT BOLD CATHETER IN THE MID-FEMORAL VEIN. THE PATIENT REPORTED EXPERIENCING SIGNIFICANT DISCOMFORT. THE PHYSICIAN WAS ABLE TO SLOWLY POSITION THE CORING ELEMENT INTO THE FUNNEL, BUT IT WOULD NOT GO FURTHER. AN ATTEMPT WAS MADE TO REMOVE THE CT SHEATH AND THE CT BOLD CATHETER TOGETHER, BUT THIS WAS NOT POSSIBLE. REVIEW OF THE COMPUTER TOMOGRAPHY SCAN REVEALED THAT THE CT BOLD HAD LIKELY CAPTURED CALCIUM THAT WAS PRESENT AT THE ORIGIN OF THE LEFT COMMON ILIAC VEIN. UNFORTUNATELY, THE CT BOLD BROKE FROM THE STRESS INDUCED BY EXCESSIVE MANIPULATION DURING REMOVAL ATTEMPTS. A SMALL VENOUS CUTDOWN WAS PERFORMED A

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Vascular Dissection

  MAUDE report 18823152 ↗
• InjuryFeb 7, 2024Entrapment of Device; Use of Device Problem; Entrapment of Device; Use of Device Problem

  AN (B)(6) MALE PATIENT WITH A PREEXISTING DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LOWER EXTREMITY UNDERWENT A THROMBECTOMY ON (B)(6) 2024 USING THE CLOTTRIEVER SYSTEM. THE CLOT AGE WAS ESTIMATED AT 21 DAYS. THE PATIENT WAS PLACED IN THE PRONE POSITION AND LEFT POPLITEAL ACCESS WAS OBTAINED. INTRAVENOUS ULTRASOUND (IVUS) WAS PERFORMED WHICH REVEALED VENOUS COMPRESSION AND THROMBUS. THE CLOTTRIEVER SHEATH 13 FR AND CLOTTRIEVER BOLD CATHETER (CT BOLD) WERE PLACED INTO POSITION. FOUR PASSES WERE MADE WITH THE CT BOLD WHICH REMOVED LONG CHRONIC CLOT. AN ABRE 16X20 VENOUS STENT WAS PLACED AND BALLOONED WITH A 16X40 BALLOON. A VENOGRAM REVEALED 90% OF THE DVT WAS REMOVED, WITH THROMBUS REMAINING BELOW THE STENT. A FLOWTRIEVER 2 WAS USED DISTAL FROM THE STENT AND TWO PASSES WERE PERFORMED, HOWEVER, NO CLOT WAS REMOVED. THE CT BOLD WAS THEN ADVANCED INTO THE STENT WITH THE COLLECTION BAG POSITIONED IN THE STENT AND THE CORING ELEMENT BELOW THE STENT. A PASS WAS PERFORMED, BUT NO CLOT WAS REMOVED. ANOTHER PASS WAS PERFORMED, BUT THE TOP OF THE STENT WAS INADVERTENTLY PULLED DOWN OVER ITSELF. THE PROCEDURE WAS PAUSED TO RE-SHEATH THE CT BOLD; HOWEVER, MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. THE P

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 18665261 ↗
• DeathDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 78-YEAR-OLD FEMALE WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM. THE CLOT AGE WAS ESTIMATED AT 5 DAYS. THE PROCEDURE WAS PERFORMED UNDER MONITORED ANESTHESIA WITH THE PATIENT IN A PRONE POSITION. WIRE POSITIONING WAS SUCCESSFULLY OBTAINED AND THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED. TWO PASSES WERE PERFORMED BEFORE THE HEART RATE DECREASED FROM A BASELINE OF 75 BPM TO THE 60 RANGE. THE PATIENT CONTINUED TO DETERIORATE AS IMAGING WAS ATTEMPTED. A VENOGRAM OF THE LOWER LEFT EXTREMITY REVEALED NO CLOT BURDEN INDICATING A POTENTIAL EMBOLISM. THE HEART RATE FURTHER DECLINED (50 BPM RANGE) AND THE PATIENT WAS REPOSITIONED SUPINE. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED AND THE PATIENT WAS INTUBATED. THE PULMONARY ANGIOGRAM CONFIRMED A PULMONARY EMBOLISM ON THE LEFT SIDE AND THE SURGEON CONVERTED TO USE OF THE FLOWTRIEVER. WIRE POSITIONING WAS OBTAINED AND A TRIEVER24 (T24) WAS INSERTED BUT WOULD NOT ADVANCE PAST THE CURVATURE OF THE LEFT PULMONARY ARTERY; A TRIEVER20 CURVE (T20C) WAS THEN TELESCOPED THROUGH THE T24. AN ASPIRATION WAS PERFORMED WHICH RESULTED IN AN OBSTRUCTION. THE DEVICE WAS REMOVED FROM

  Patient problems: Bradycardia; Cardiac Arrest; Pulmonary Embolism

  MAUDE report 18399612 ↗
• InjuryNov 22, 2023Difficult to Remove; Difficult to Advance; Difficult or Delayed Separation; Difficult to Remove; Difficult to Advance; Difficult or Delayed Separation

  A 65-YEAR-OLD MALE WITH RIGHT UPPER EXTREMITY DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM. THE PATIENT HAD A RECENT HISTORY OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND DEVELOPED A DVT INVOLVING THE RIGHT BASILIC, BRACHIAL, AND AXILLARY VEINS. THE CLOT AGE WAS ESTIMATED AT 7 DAYS. ACCESS WAS OBTAINED IN THE RIGHT BRACHIAL VEIN WITH A MICRO PUNCTURE KIT AND UPSIZED TO AN 8 FR SHEATH. A GLIDEWIRE ADVANTAGE AND RUBICON CROSSING CATHETER WERE USED TO PLACE THE GLIDEWIRE INTO THE INFERIOR VENA CAVA (IVC). THE 13 FR CLOTTRIEVER SHEATH WAS INSERTED WITH THE BASKET FULLY DEPLOYED FOLLOWED BY INSERTION OF THE CLOTTRIEVER BOLD CATHETER (CT BOLD). THREE PASSES WERE PERFORMED IN THE SUPERIOR VENA CAVA (SVC) WHICH REMOVED SUB-ACUTE CLOT. ON THE 4TH PASS, THE CT BOLD CATHETER WAS PULLED INTO THE CT SHEATH WHERE THE PHYSICIAN REPORTED SENSING EXTREME RESISTANCE AND WAS UNABLE TO EXTRACT THE CATHETER FROM THE SHEATH. EVENTUALLY, THE CATHETER WAS RECAPTURED WITHIN THE SHEATH AND THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER. UPON REMOVAL, CHRONIC CLOT WAS NOTICED WITH SOME GREEN/WHITE PLASTIC MATERIAL. THE DEVICES WERE INTACT WHEN REMOVED. A

  Patient problems: Vascular Dissection

  MAUDE report 18196815 ↗
• DeathJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66-YEAR-OLD MALE PATIENT WAS DIAGNOSED WITH LEFT LOWER EXTREMITY ILIO-FEMORAL DEEP VEIN THROMBOSIS (DVT). THE CLOT AGE WAS ESTIMATED AT 3 DAYS. ON (B)(6) 2023, A THROMBECTOMY WAS PLANNED WITH THE INARI CLOTTRIEVER (CT) BOLD CATHETER WITH LEFT POPLITEAL ACCESS. A VENOGRAM WAS PERFORMED WHICH REVEALED EXTENSIVE CLOT BURDEN FROM THE POPLITEAL VEIN TO THE ILIAC VEIN. NO CLOT WAS IDENTIFIED IN THE INFERIOR VENA CAVA (IVC). THE SURGICAL PLAN WAS TO PERFORM THE THROMBECTOMY WITHOUT DISTAL PROTECTION DUE TO THE CLOT LOCATION. WIRE POSITIONING WAS OBTAINED WITH AN AMPLATZ GUIDEWIRE, AND THE CT BOLD CATHETER WAS ADVANCED. THREE PASSES WERE PERFORMED WHICH SUCCESSFULLY RETRIEVED A LARGE CLOT BURDEN. A VENOGRAM WAS TAKEN AFTER THE THIRD PASS WHICH REVEALED A LARGE THROMBUS IN THE ILIAC/IVC HAD FLOATED UP FROM WHAT WAS PRESUMED TO BE THE PROFUNDA ARTERY. THE PHYSICIAN REPOSITIONED TO ADDRESS THIS CLOT. A FOURTH PASS WAS MADE, BUT IT DID NOT COLLECT A SUFFICIENT AMOUNT OF CLOT. AT THIS POINT, THE PATIENT BECAME RESTLESS, TACHYCARDIC, AND HYPOXIC. A PULMONARY EMBOLISM (PE) WAS SUSPECTED AND THE PATIENT WAS REPOSITIONED FROM THE PRONE POSITION TO SUPINE IN ORDER TO ACCESS THE RIGHT COMMON FEMORA

  Patient problems: Anxiety; Cardiac Arrest; Low Oxygen Saturation; Pulmonary Embolism; Tachycardia

  MAUDE report 17269174 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 71-YEAR-OLD FEMALE WITH LEFT LEG DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM AFTER EXPERIENCING SYMPTOMS FOR 2 DAYS. THE PATIENT'S HIGH CREATININE LEVEL LIMITED THE EXTENT OF FLUOROSCOPIC IMAGING; ALTHOUGH VISUALIZATION OF THE INFERIOR VENA CAVA (IVC) WAS SUB-OPTIMAL, THE PHYSICIAN DEEMED IT SUFFICIENT TO INITIATE THE PROCEDURE. THE PATIENT WAS PLACED IN THE PRONE POSITION AND THE LEFT POPLITEAL VEIN WAS CANNULATED. A GLIDEWIRE ADVANTAGE WAS USED TO NAVIGATE THE IVC; THE WIRE MET RESISTANCE AT THE CONFLUENCE AND THEN CROSSED INTO THE CONTRALATERAL SIDE (RT) COMMON ILIAC. A CLOTTRIEVER SHEATH 13 FR WAS INSERTED AND THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED. AFTER THE FIRST PASS, THE PATIENT REPORTED EXPERIENCING PAIN AND THE HEART RATE AND OXYGEN SATURATION (SPO2) DECREASED. ADDITIONAL SEDATION WAS ADMINISTERED AND A SECOND PASS WAS PERFORMED WHICH RESULTED IN A SUBSEQUENT DECREASE IN HEART RATE (HR) AND SPO2. THE PATIENT BECAME UNRESPONSIVE WITH SPO2 FLUCTUATION, BUT NO CHANGE IN HR. THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS MOVED TO A BED FOR OBSERVATION. DURING OBSERVATION, THE PATIENT DECOMPENSATED AND A CODE WAS INI

  Patient problems: Bradycardia; Cardiac Arrest; Hypoxia; Intraoperative Pain; Loss of consciousness; Pulmonary Embolism; Renal Impairment

  MAUDE report 17139927 ↗
• DeathMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT IN HER 50S WITH A HISTORY OF CONGESTIVE HEART FAILURE (CHF) AND HYPERTENSION PRESENTED WITH LEFT LEG SWELLING AND PAIN. THE PATIENT WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS (DVT) IN THE LEFT COMMON FEMORAL, LEFT COMMON ILIAC, LEFT EXTERNAL ILIAC, AND LEFT FEMORAL VEINS; THE CLOT AGE WAS ESTIMATED AT 4 DAYS. ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM. ONCE THE CLOT WAS CONFIRMED USING INTRAVASCULAR ULTRASOUND (IVUS) AND AN 8 FR CORDIS SHEATH, A CLOTTRIEVER SHEATH WAS PLACED AND CLOTTRIEVER BOLD CATHETER WAS ADVANCED AFTER WIRE POSITIONING WAS OBTAINED. HEPARIN WAS ADMINISTERED DURING THE CASE (7,000 UNITS TOTAL) AND 4 CATHETER PASSES WERE PERFORMED WHICH REMOVED 100% OF THE CLOT AS CONFIRMED VIA ANGIOGRAM. THE CLOT REMOVED WAS DESCRIBED AS VERY ACUTE. THE CLOTTRIEVER BOLD CATHETER WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN INTRODUCED IVUS TO CONFIRM CLOT REMOVAL AND TO MEASURE FOR STENTING WHEN THE PATIENT BECAME UNRESPONSIVE. THE PATIENT WAS REPOSITIONED FROM PRONE TO SUPINE AND TEGADERM DRESSING WAS PLACED OVER THE POPLITEAL ACCESS SITE AND CPR WAS INITIATED. A BOLUS OF TPA WAS ADMINISTERED ONCE THE PATIENT BECAME R

  Patient problems: Cardiac Arrest; Loss of consciousness

  MAUDE report 16594903 ↗
• InjuryOct 25, 2022Entrapment of Device; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A 14-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL WITH LEFT LEG PAIN AND SWELLING. COMPUTED TOMOGRAPHIC VENOGRAPHY (CTV) REVEALED THROMBUS IN THE LEFT POPLITEAL VEIN, SUPERFICIAL FEMORAL VEIN (SFV), COMMON FEMORAL VEIN (CFV), AND ILIAC VEIN, EXTENDING APPROXIMATELY 1 CM INTO THE INFERIOR VENA CAVA (IVC). CTV ALSO SHOWED SEGMENTAL PULMONARY EMBOLISM (PE) WITH NO RIGHT HEART STRAIN AND NO OTHER SYMPTOMS OF PE AT THAT TIME. MAY-THURNER SYNDROME WAS SUSPECTED, BUT NOT IDENTIFIED ON INITIAL IMAGING. A THROMBECTOMY WAS SCHEDULED FOR SEPTEMBER 26, 2022 USING THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM. THE PHYSICIAN ELECTED NOT TO USE EMBOLIC PROTECTION AS THEY DID NOT WANT ANOTHER ACCESS SITE. THE PLAN WAS TO USE THE CT FROM THE LEFT POPLITEAL TO TREAT THE THROMBOSED VEINS. THE SURGICAL PLAN ALSO INCLUDED USE OF ARTERIAL VASCULAR ULTRASOUND (AVUS) AND ABRE STENTS WERE READY IN THE EVENT COMPRESSION WAS FOUND. THE PATIENT WAS PLACED IN A PRONE POSITION AND ULTRASOUND WAS USED TO IMAGE THE ACCESS SITE. AN 8 X 40 BALLOON WAS USED TO BALLOON THE LANDING ZONE FOR BETTER CT SHEATH PLACEMENT. AFTER THE CT SHEATH WAS DEPLOYED, THE PATIENT REPORTED SEVERE PAIN AT THE BACK

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hypoxia; Pulmonary Embolism; Tachycardia

  MAUDE report 15670558 ↗