ClotTriever Sheath, 13 Fr 50-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00850291007109), received between Dec 5, 2017 and Aug 25, 2026 — classified as 3 deaths, 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439779 ↗
• InjuryApr 1, 2026Entrapment of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. WHEN INSERTING THE SHEATH INTO THE LEFT POPLITEAL VEIN, THE FUNNEL DID NOT FULLY OPEN. AS SUCH, AN 8 X 40 BALLOON WAS USED TO EXPAND THE FUNNEL SUCCESSFULLY. THE REMAINDER OF THE CASE WAS PERFORMED THE USUAL WAY PERFORMING A TOTAL OF 3 PASSES. AFTER THE PASSES, AN IVUS CATHETER WAS USED TO DETERMINE CLOT CLEARANCE AND LOOK FOR COMPRESSION OF THE LEFT COMMON ILIAC VEIN. A COMPRESSION WAS NOTED AND THE PHYSICIAN DETERMINED HE WILL STAGE IT AND BRING BACK ANOTHER TIME. A FIGURE 8 SUTURE WAS PERFORMED AROUND THE SHEATH AND FLOWSTASIS WAS ENGAGED FOR REMOVAL OF SHEATH. ATTEMPTING TO REMOVE THE SHEATH WAS NOT SUCCESSFUL, AS THE SHEATH WOULD NOT COME OUT. USE OF HEPARINIZED SALINE TO COAT THE SHEATHS HYDROPHILIC COATING WAS ATTEMPTED, SKIN NICK WAS ATTEMPTED, AND INSERTING DILATOR WHILE ATTEMPTING TO REMOVE WAS ATTEMPTED. SEVERAL VENOGRAMS WERE PERFORMED TO VISUALIZE THE FUNNEL AND VEIN. THE FUNNEL AND VEIN APPEARED NORMAL IN IMAGING. THE PATIENT WAS HAVING PAIN DURING THE REMOVAL ATTEMPTS. A VASCULAR SURGEON WAS CALLED TO THE ROOM AND DETERMINED THE PATIENT NEEDED A CUTDOWN OF THE POPLIT

  Patient problems: Pain

  MAUDE report 24756218 ↗
• MalfunctionMar 4, 2026Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY USING THE CLOTTRIEVER SYSTEM OF DEVICES. DURING THE PROCEDURE, A CLOTTRIEVER SHEATH HEMOSTASIS VALVE SEPARATED FROM THE REST OF THE CATHETER. ADDITIONAL PRODUCT WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508355 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE CLOTTRIEVER SHEATH, 13 FR. (CT SHEATH) WAS REMOVED FROM THE PATIENT TO FLUSH THE DEVICE AND THEN WAS REINTRODUCED INTO THE PATIENT. AFTER REINSERTION, THE CT SHEATH WAS PULLED BACK A FEW CENTIMETERS AND THE HEMOSTASIS VALVE SEPARATED FROM THE SHEATH SHAFT. WIRE ACCESS WAS STILL MAINTAINED. THE PHYSICIAN PERFORMED A LARGER SKIN NICK AND THE SHEATH SHAFT WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT'S VASCULATURE USING HEMOSTATS. THE SHEATH SHAFT AND FUNNEL REMAINED INTACT. THE PROCEDURE WAS RESUMED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507757 ↗
• InjuryOct 23, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 62-YEAR-OLD MALE UNDERWENT A SUCCESSFUL DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING THE INARI CLOTTRIEVER SYSTEM. APPROXIMATELY TWO MONTHS AFTER, ON (B)(6) 2025, THE PATIENT PRESENTED WITH A SECOND DVT AFTER HE HAD STOPPED TAKING HIS MEDICATION, ELIQUIS, AND REOCCLUDED. DURING THE VISIT ON (B)(6) 2025, IT WAS IDENTIFIED THAT THE PATIENT HAD A SEGMENT OF A CLOTTRIEVER SHEATH, 13 FR IN HIS POPLITEAL VEIN, SPECIFICALLY THE FUNNEL AND SMALL PART OF THE CATHETER. THE DECISION WAS MADE NOT TO REMOVE THE FUNNEL AS REMOVING IT MAY CAUSE MORE TRAUMA.

  Patient problems: Foreign Body In Patient

  MAUDE report 23375000 ↗
• InjuryJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B(6), 2025 A MALE PATIENT UNDERWENT A DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 10 DAYS OLD. DURING THE THROMBECTOMY, THE PATIENT WAS POSITIONED FROG-LEGGED. A CLOTTRIEVER SHEATH, 13 FR (CT SHEATH) WAS USED TO INSERT THE DEVICES. DURING THE PROCEDURE, THE SHEATH SHAFT SEPARATED FROM THE CT SHEATH HEMOSTASIS VALVE WITH THE PROXIMAL TIP PROTRUDING FROM THE ACCESS SITE. DUE TO THE PATIENT'S POSITIONING, THE MEDICAL TEAM DID NOT NOTICE THE SHEATH WAS LEAKING BLOOD IMMEDIATELY. AS A RESULT OF THE BLOOD LOSS, THE PATIENT'S HEMOGLOBIN DROPPED FROM 12G/DL TO 9G/DL, HOWEVER THE PATIENT DID NOT SHOW SIGNS OF DETERIORATION. THE PATIENT REMAINED STABLE, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES AFTER THE CT SHEATH WAS REPLACED. POST PROCEDURE, THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO THE HEMOGLOBIN DROP AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) TO RECOVER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22470686 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 24-YEAR-OLD MALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT WAS BEING TREATED FOR TESTICULAR CANCER AND A HISTORY OF PULMONARY EMBOLISM THAT WAS TREATED IN (B)(6) 2025. THE PATIENT HAD A MASS IN HIS LEFT COMMON ILIAC, WHICH TOTALLY OCCLUDED THE VEIN. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 60 DAYS. EXTRAVASATION WAS OBSERVED AFTER THE CLOTTRIEVER SHEATH, 13FR (CT SHEATH) WAS INSERTED INTO THE PATIENT'S LEFT POPLITEAL VEIN AND AN ATTEMPT WAS MADE TO ADVANCE THE CLOTTRIEVER BOLD. THE MEDICAL TEAM MADE THE DECISION TO USE THE PATIENT'S INTERNAL JUGULAR VEIN AS AN ACCESS SITE. WHILE THE NEW CT SHEATH WAS BEING PLACED INTO THE PATIENT'S INTERNAL JUGULAR, THE MEDICAL TEAM NOTICED THE DILATOR WAS BENDING WHILE BEING INSERTED. THE CT SHEATH WAS ADVANCED, AND THE FUNNEL WAS DEPLOYED. A VENOGRAM SHOWED SOME EXTRAVASATION. AN ATTEMPT WAS MADE TO TRACK A BALLOON OVER THE WIRE; HOWEVER, THE BALLOON COULD NOT BE ADVANCED. THE MEDICAL TEAM DECIDED TO USE ANOTHER SHEATH AND WHILE REMOVING THE CT SHEATH, THE PHYSICIAN NOTICED THE FUNNEL WAS NO LONGER CONNECTED TO THE DISTAL END OF THE CT SHEATH. FLUOROSCOPY IMAGING REVEALED THAT THE FUNNEL R

  Patient problems: Foreign Body In Patient

  MAUDE report 22377471 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  ON (B)(6) 2025 A 51-YEAR-OLD FEMALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 365 DAYS. AFTER MULTIPLE PASSES, THE FUNNEL OF THE CLOTTRIEVER SHEATH, 13 FR (CT SHEATH) SEPARATED FROM THE SHEATH SHAFT. THE FUNNEL WAS ABLE TO BE REMOVED WITH HEMOSTATS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755212 ↗
• InjuryFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN INDIVIDUAL UNDERWENT A THROMBECTOMY USING THE INARI CLOTTRIEVER (CT) SYSTEM TO TREAT THEIR RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS. AFTER WIRE POSITIONING WAS ACCOMPLISHED USING A 260CM GLIDE ADVANTAGE WIRE, A 13 FR. CT SHEATH WAS OPENED AND PREPPED. AN 8 FR. SHEATH WAS REMOVED AND THE INARI PREPACKAGED PRE-DILATOR WAS UTILIZED TO DILATE THE ACCESS SITE. THE DILATOR WAS REMOVED AND THE 13FR. SHEATH WAS INSERTED. THE CT SHEATH WAS DEPLOYED IN NORMAL ORDER AND THE MOUNTED DILATOR WAS REMOVED. THE CT CATHETER WAS PREPPED AND THEN INSERTED. 2 PASSES WERE MADE WHICH YIELDED CLOT. AT THIS POINT, THE GLIDE ADVANTAGE WIRE WAS NOTED TO HAVE MOVED BACKWARDS AND SO THE PHYSICIAN ELECTED TO RE-POSITION. IMAGING WAS PERFORMED WHEN A SMALL "CONE SHAPED" RADIOPAQUE OBJECT WAS SEEN. BASED ON ITS SIZE, IT WAS CONCLUDED THAT IT WAS NOT THE TIP OF THE CT CATHETER. INSPECTION BEGAN ON ALL PRODUCTS THAT WERE UTILIZED UP TO THAT POINT. THIS WAS WHEN IT WAS NOTICED THAT THE CT SHEATH'S DILATOR WAS MISSING ITS TIP. THE PHYSICIAN BEGAN TO SLOWLY PULL BACK THE GUIDEWIRE AS THE TIP APPEARED TO BE SLIGHTLY FIXED TO THE END, HOWEVER, THE TIP DISLODGED AND MIGRATED TO A SUB-SEGMENTAL BRANCH IN THE RIGHT P

  Patient problems: Foreign Body In Patient

  MAUDE report 21429013 ↗
• InjuryDec 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON OCTOBER 9, 2023, A SUCCESSFUL DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY WAS PERFORMED USING THE INARI CLOTTRIEVER SYSTEM. ON (B)(6) 2023, THIS PATIENT UNDERWENT FOREIGN BODY REMOVAL; IMAGING REVEALED THAT THE FOREIGN BODY ORIGINATED FROM AN INARI CLOTTRIEVER SHEATH (DISTAL 1 CM OF THE SHEATH AND FUNNEL). THE MATERIAL REMOVED FROM THE PATIENT HAD A CLEAN CUT, LIKELY FROM CONTACT WITH A SCALPEL. THE HOSPITAL IS IN CURRENT POSSESSION OF THE DEVICE FRAGMENT AND IS PERFORMING AN INTERNAL ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411122 ↗
• InjuryDec 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 53-YEAR-OLD FEMALE WITH A HISTORY OF STAGE 4 BREAST CANCER AND ONGOING GASTROINTESTINAL (GI) ILLNESS PRESENTED TO THE EMERGENCY DEPARTMENT WITH EXERTIONAL DYSPNEA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DURING HER STAY THE PATIENT DEVELOPED RIGHT UPPER EXTREMITY SWELLING UNRESOLVED BY THE LYMPHEDEMA PUMP. A DUPLEX ULTRASOUND WAS PERFORMED WHICH REVEALED DEEP VEIN THROMBOSIS (DVT) IN THE UPPER RIGHT EXTREMITY. A THROMBECTOMY WAS SCHEDULED WITH THE INARI CLOTTRIEVER SYSTEM. DURING THE THROMBECTOMY, THE PATIENT'S RIGHT BRACHIAL VEIN WAS UTILIZED AS THE ACCESS SITE. THE PROCEDURE WAS SUCCESSFUL, AND THE COMPLETE THROMBUS WAS REMOVED. THE POST-PROCEDURE VENOGRAM AND INTRAVASCULAR ULTRASOUND REVEALED RESTORED PATENCY. HOWEVER, UPON REMOVAL OF THE CLOTTRIEVER SHEATH 13 FR, A SMALL SEGMENT OF THE PATIENT'S BRACHIAL VEIN AVULSED OUTSIDE THE ARM. THE PHYSICIAN TIED DOWN THE VEIN AND SURGICALLY SUTURED IT TO CONTROL BLEEDING. MINIMAL BLOOD LOSS WAS NOTED AND NO OTHER COMPLICATIONS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.

  Patient problems: Perforation of Vessels

  MAUDE report 18323429 ↗
• InjuryDec 1, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  A 65-YEAR-OLD MALE PATIENT WITH DEEP VEIN THROMBOSIS (DVT) IN THE UPPER LEFT EXTREMITY UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER BOLD CATHETER. THE CLOT AGE WAS ESTIMATED AT 15 DAYS. THE TREATMENT WAS SUCCESSFUL WITH REMOVAL OF THE ENTIRE CLOT; HOWEVER, WHEN PREPARING FOR CLOSURE, THE PHYSICIAN FELT RESISTANCE AS THE CLOTTRIEVER SHEATH WAS BEING REMOVED FROM THE ACCESS SITE IN THE BASILIC VEIN. THE PHYSICIAN APPLIED EXCESSIVE FORCE TO ENABLE REMOVAL OF THE SHEATH AND UPON REMOVAL, IT WAS NOTICED THAT THE BASILIC VEIN HAD TORN. A VENOGRAM WAS PERFORMED WHICH REVEALED NO HARM TO THE DEEP VENOUS SYSTEM. THE ARM WAS WRAPPED WITH A COMPRESSION BANDAGE AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Vascular Dissection

  MAUDE report 18253159 ↗
• InjurySep 26, 2023Collapse; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Collapse; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  A FEMALE IN HER EARLY 40S WAS DIAGNOSED WITH A LEFT UPPER EXTREMITY DEEP VEIN THROMBOSIS (DVT). THE CLOT AGE WAS APPROXIMATELY 20 DAYS. THE PATIENT WAS SCHEDULED TO UNDERGO A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM. ACCESS WAS ATTEMPTED AT THE LEFT BASILIC VEIN. THE PHYSICIAN DILATED AND INSERTED THE CLOTTRIEVER 13 FR SHEATH. AT THIS POINT, IT WAS ASSUMED THAT THE DILATOR BECAME CAUGHT ON A VALVE OR NARROW VEIN SEGMENT. AFTER THE FUNNEL WAS DEPLOYED APPROPRIATELY, THE DILATOR BECAME STUCK IN THE VESSEL AND WAS UNABLE TO BE REMOVED. EACH ATTEMPT TO RETRACT THE DILATOR CRUSHED THE FUNNEL. THE SHEATH WAS REMOVED FROM THE PATIENT AND ADDITIONAL DILATION AND BALLOONING OF THE ACCESS SITE WAS PERFORMED TO REMOVE THE DILATOR; HOWEVER, THE BASILIC VEIN TORE DURING DEVICE REMOVAL. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED THE SAME DAY IN STABLE CONDITION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN WHO REPORTED THAT THE PATIENT'S VEINS ARE VERY RESILIENT AND THE VEIN WAS EXPECTED TO CLOSE OFF.

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

  MAUDE report 17822244 ↗
• InjuryApr 6, 2023Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2023, A 55-YEAR-OLD FEMALE HEMODIALYSIS PATIENT UNDERWENT A THROMBECTOMY FOR EXTENSIVE CLOT IN THE LEFT SUBCLAVIAN VEIN EXTENDING DOWN THE ARM. THE CLOT AGE WAS APPROXIMATELY 90 DAYS. THE PHYSICIAN DILATED UP TO 14 FR AND INSERTED A 13 FR CLOTTRIEVER (CT) SHEATH. UPON INITIAL INSERTION OF THE FIRST CT SHEATH, EXCESSIVE MANIPULATION RESULTED IN A DENT AND DAMAGE TO THE DILATOR. A SECOND CT SHEATH WAS OPENED AND INSERTED. UPON INSERTION OF THIS SECOND SHEATH, THE DILATOR BECAME STUCK IN THE PATIENT. VARIOUS METHODS WERE EMPLOYED TO REMOVE THE DILATOR, INCLUDING MANUAL MANIPULATION, ORAL ADMINISTRATION OF NITROGLYCERIN, APPLICATION OF A TOURNIQUET, AND APPLICATION OF PRESSURE TO THE ARMPIT. UNFORTUNATELY, THESE EFFORTS WERE UNSUCCESSFUL AND THE PATIENT WAS SENT TO THE OPERATING ROOM FOR A VENOUS CUTDOWN. THE CT SHEATH WAS EMBEDDED IN THE BRACHIAL VEIN, THROUGH A COLLATERAL, AND HAD PUNCTURED THE BRACHIAL ARTERY. ON MARCH 30, 2023, INARI RECEIVED A USER FACILITY MEDWATCH REPORT#: (B)(4) FROM THE FDA VIA THE MEDSUN PROGRAM. THIS REPORT DESCRIPTION WAS AS FOLLOWS: PATIENT HAD LEFT UPPER EXTREMITY DVT (DEEP VEIN THROMBOSIS) WITH LIMITED ACCESS DUE TO HEMODIALYSIS. THE 13 FR INAR

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

  MAUDE report 16694130 ↗
• InjuryMar 18, 2022Break; Entrapment of Device; Break; Entrapment of Device

  A MALE PATIENT IN HIS EARLY (B)(6) WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT ILIAC VEIN. THE PATIENT UNDERWENT CLOT REMOVAL WITH THE INARI CLOTTRIEVER (CT). A 13FR CT SHEATH WAS INSERTED AND THE CT CATHETER WAS DEPLOYED; 4 PASSES OF THE CT CATHETHER YIELDED RETRIEVAL OF 97% OF THE CLOT BURDEN. FOLLOWING SUCCESSFUL CLOT REMOVAL THE TECHNICIAN FELT RESISTANCE WHILE ATTEMPTING TO REMOVE THE CT SHEATH FROM THE PATIENT. THE VASCULAR SURGEON TOOK OVER AND PULLED ON THE CT SHEATH. IN THIS PROCESS, THE SHEATH BECAME SEPARATED WITH HALF OF THE SHEATH BEING REMOVED AND HALF REMAINING IN THE PATIENT. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN SHEATH USING FORCEPS, BUT WAS UNSUCCESSFUL AND A VENOUS CUTDOWN WAS PERFORMED IN ORDER TO REMOVE THE CT SHEATH. THE REMOVAL WAS SUCCESSFUL AND UNEVENTFUL. THE SURGEON ATTRIBUTED THE BROKEN SHEATH TO A VASOSPASM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13814260 ↗
• InjuryJun 22, 2021Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method

  A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL WITH UPPER EXTREMITY DEEP VEIN THROMBOSIS (DVT) EXTENDING FROM THE PROXIMAL BASILIC VEIN TO THE SUBCLAVIAN. ON (B)(6) 2021, THE INARI MEDICAL CLOTTRIEVER (CT) WAS USED TO ATTEMPT TO TREAT THE DVT. AFTER ULTRASOUND-GUIDED ACCESS WAS OBTAINED, A COOK MEDICAL BENTSON WIRE GUIDE WAS ADVANCED BEFORE BEING EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE. A PHILLIPS VISIONS PV .035 DIGITAL IVUS CATHETER WAS THEN USED TO CONFIRM CLOT LOCATION AND VESSEL SIZE. THE VESSEL WAS DILATED WITH A 14F COONS DILATOR, THE CT SHEATH WAS INSERTED OVER THE GUIDEWIRE, AND THE CT DILATOR WAS ADVANCED. AFTER DILATION, THE PHYSICIAN BEGAN TO WITHDRAW THE CT DILATOR AND ENCOUNTERED SUBSTANTIAL RESISTANCE. THE PHYSICIAN PAUSED REMOVAL TO MAKE A SMALL INCISION IN THE VEIN BEFORE CONTINUING. WHILE ATTEMPTING TO REMOVE THE DEVICES, IT WAS NOTED THAT THE VEIN WALL WAS BEING STRIPPED. AFTER THE DEVICES WERE REMOVED, THE PHYSICIAN LIGATED THE VEIN, AND THE PROCEDURE WAS CONCLUDED. THE PHYSICIAN NOTED THAT ENGAGING THE CT DILATOR TABS DURING WITHDRAWAL MAY HAVE CAUSED THE DEVICE TO CATCH THE VEIN WALL, PULLING IT DOWN AND CATCHING IT IN THE S

  Patient problems: Vascular Dissection

  MAUDE report 12047018 ↗
• 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 11219605 ↗
• 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 SUBMASSIVE 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 10248832 ↗
• 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 10097525 ↗
• InjuryFeb 19, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A (B)(6)-YEAR-OLD OBESE FEMALE PATIENT ADMITTED THROUGH THE EMERGENCY DEPARTMENT WITH A HISTORY OF VENOUS THROMBOEMBOLISM WAS TREATED FOR DEEP VEIN THROMBOSIS WITH CLOT PRESENT IN THE LEFT COMMON ILIAC, LEFT EXTERNAL ILIAC, LEFT COMMON, AND LEFT POPLITEAL VEINS. ON (B)(6) 2020, THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM WAS USED DURING A PERIPHERAL THROMBECTOMY TREATMENT. NO COMPANY PERSONNEL WERE PRESENT DURING THE PROCEDURE. AFTER PLACEMENT OF THE CLOTTRIEVER SHEATH IN THE LEFT POPLITEAL VEIN, THE TREATING PHYSICIAN AND FELLOW NOTED RESISTANCE WHEN ATTEMPTING TO REMOVE THE CLOTTRIEVER SHEATH'S DILATOR FROM THE SHEATH POST-DEPLOYMENT OF THE FUNNEL. THE DILATOR WAS GETTING CAUGHT ON CLOTTRIEVER SHEATH'S FUNNEL. THE DECISION WAS MADE TO REMOVE THE CLOTTRIEVER SHEATH AND DILATOR TOGETHER, BUT EXCESSIVE FORCE WAS USED. UPON DEVICE REMOVAL FROM THE PATIENT, THE POPLITEAL VEIN WAS INADVERTENTLY REMOVED. THE PHYSICIAN REINSERTED THE VEIN USING HEMOSTATS. THE PROCEDURE CONTINUED BY PLACING GORE'S 12 FR DRYSEAL INTRODUCER SHEATH THROUGH WHICH THE CLOTTRIEVER CATHETER WAS USED TO COMPLETE THE THROMBECTOMY PROCEDURE WITHOUT COMPLICATION. FOLLOWING THE PROCEDURE, CT ANGIOGRAPHY AND ULTRASOUND

  Patient problems: Prolapse

  MAUDE report 9728300 ↗
• DeathSep 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, A (B)(6) YEAR-OLD FEMALE PATIENT WAS DIAGNOSED WITH AN ACUTE PULMONARY EMBOLISM VIA CT ANGIOGRAM WITH THE PRESENCE OF BILATERAL THROMBUS AND RIGHT HEART STRAIN; THE PATIENT ALSO HAD PREEXISTING DEEP VEIN THROMBOSIS (THE PLAN WAS TO PLACE AN IVC FILTER IMMEDIATELY FOLLOWING PULMONARY THROMBECTOMY). TWO DAYS PRIOR, THE PATIENT HAD UNDERGONE EXPLORATORY LAPAROTOMY AND SIGMOID COLECTOMY. VASCULAR ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL VEIN. A ROSEN GUIDEWIRE (COOK MEDICAL) WITH ANGLED PIGTAIL CATHETER WAS USED TO CROSS THE HEART AND ACCESS THE MAIN PULMONARY ARTERY. THE PIGTAIL CATHETER WAS THEN SWAPPED FOR A COBRA C2 CATHETER (MERIT MEDICAL). THE ROSEN GUIDEWIRE WAS SWAPPED FOR A SUPRACORE 300 CM GUIDEWIRE (ABBOTT). A DRYSEAL 20 FR INTRODUCER SHEATH (GORE) WAS PLACED INTO THE RIGHT COMMON FEMORAL VEIN INTO WHICH THE TRIEVER20 (INARI MEDICAL) WAS ADVANCED THROUGH THE RIGHT ATRIUM INTO THE RIGHT VENTRICLE. HOWEVER, THE TRIEVER20 WAS UNABLE TO BE ADVANCED INTO THE PULMONARY VALVE OR PULMONARY ARTERY. THE PRIMARY OPERATOR THOUGHT THAT THE GUIDEWIRE HAD BENT AND REQUESTED A NEW SUPRACORE 300 CM WIRE. WHILE RETRACTING THE TRIEVER20 OUT OF THE RIGHT VENTRICLE THE PATI

  Patient problems: Cardiac Perforation; Death; Pericardial Effusion

  MAUDE report 9014654 ↗
• InjuryAug 13, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(4) 2019, INARI BECAME AWARE VIA SOCIAL MEDIA OF AN ADVERSE EVENT INVOLVING THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM WHICH WAS BEING USED DURING A PERIPHERAL THROMBECTOMY TREATMENT. THE POSTING DESCRIBED AN EVENT THAT OCCURRED ON (B)(6) 2019 WHERE A PORTION OF THE PATIENT'S RIGHT SAPHENOUS VEIN WAS INADVERTENTLY EXTRACTED. FOLLOW-UP INFORMATION WAS REQUESTED FROM THE COMPANY REPRESENTATIVE WHO ATTENDED THE CASE. AFTER PLACEMENT OF THE CLOTTRIEVER SHEATH, THE CLOTTRIEVER CATHETER WAS INSERTED INTO WHAT WAS THOUGHT TO BE THE FEMORAL VEIN, BUT IT WOULD NOT PASS THE COMMON FEMORAL AREA. THE CLOTTRIEVER CATHETER WAS WITHDRAWN, THEN TWO ATTEMPTS WERE MADE TO DILATE THE AREA WITH A 10 MM BALLOON. AFTER EACH DILATION ATTEMPT, THE PHYSICIAN TRIED TO RE-ADVANCE THE CLOTTRIEVER CATHETER, BUT WAS STILL UNABLE TO PASS THE COMMON FEMORAL AREA. VENOGRAPHY OF THE AREA SHOWED NO CONTRAST FLOW PAST THIS AREA, LEADING TO THE CONCLUSION THAT COLLATERAL VEINS HAD FORMED. THE VASCULAR SURGEON THEREFORE ELECTED TO ABORT THE THROMBECTOMY PROCEDURE AND NOTED RESISTANCE WHILE REMOVING THE CLOTTRIEVER SHEATH. UPON REMOVAL FROM THE PATIENT, THE PHYSICIAN NOTED THAT HE HAD REMOVED AN APPROXIMATE 15 CM S

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 8886320 ↗
• DeathFeb 11, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, A PATIENT WITH A HISTORY OF PRIOR PULMONARY EMBOLISM EVENTS WAS TREATED FOR DEEP VEIN THROMBOSIS AFTER BEING ADMITTED FOR LEFT LEG PAIN AND SWELLING. THE VASCULAR SURGEON GAINED POPLITEAL ACCESS VIA A 0.035" TERUMO GLIDEWIRE PLACED THROUGH THE INFERIOR VENA CAVA. CLOT IN THE LEFT COMMON ILIAC, EXTERNAL ILIAC, AND COMMON FEMORAL WAS IDENTIFIED BY ULTRASOUND AND VERIFIED BY VENOGRAM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED DYSRHYTHMIA, LIKELY PROVOKED BY THE TERUMO GUIDEWIRE TIP BEING MISPLACED IN RIGHT HEART. THE INARI CLOTTRIEVER SHEATH WAS INTRODUCED OVER THE PREPLACED GUIDEWIRE AND THE CLOTTRIEVER CATHETER WAS INSERTED THROUGH THE CLOTTRIEVER SHEATH UPON REMOVAL OF THE SHEATH'S DILATOR. THE FIRST PASS WITH THE CLOTTRIEVER CATHETER SUCCESSFULLY REMOVED ACUTE CLOT. THE CLOTTRIEVER CATHETER WAS RE-INTRODUCED AND A SECOND PASS WAS COMPLETED. AT THIS TIME IT WAS DISCOVERED THAT THE PATIENT HAD NOT BEEN ANTICOAGULATED PRE-PROCEDURALLY, SO WITH THE CLOTTRIEVER CATHETER OUTSIDE OF THE PATIENT, THE PHYSICIAN DELIVERED A 10,000 IU BOLUS INJECTION OF HEPARIN VIA THE CLOTTRIEVER SHEATH SIDE PORT. THE PATIENT THEN COMPLAINED SHE WAS NOT FEELING WELL. HEMODYNAMICS REMAINE

  Patient problems: Cardiac Arrest; Death; Pulmonary Embolism

  MAUDE report 8329343 ↗
• InjuryDec 5, 2017Difficult to Remove; Retraction Problem; Use of Device Problem; Patient-Device Incompatibility; Difficult to Remove; Retraction Problem; Use of Device Problem; Patient-Device Incompatibility

  A PATIENT REQUIRED INTERVENTION TO TREAT BILATERAL DEEP VEIN THROMBOSIS (DVT) AFTER PREVIOUS ANGIOJET AND 24-HOUR TPA DRIP USING EKOS DEVICE. THE PHYSICIAN SUCCESSFULLY TREATED THE PATIENT'S LEFT DVT BY ASPIRATION WITH AN 8 FR CATHETER. ON THE RIGHT SIDE, THE PHYSICIAN INSERTED THE INARI CLOTTRIEVER SHEATH, MODEL 50-101, IN THE PATIENT'S RIGHT POPLITEAL VEIN MEASURING 4-5 MM IN DIAMETER VIA VENOGRAM. AFTER SUCCESSFULLY DEPLOYING THE FUNNEL BY ADVANCING THE DILATOR, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE DILATOR THROUGH THE CLOTTRIEVER SHEATH. THE PHYSICIAN RETRACTED BOTH THE CLOTTRIEVER SHEATH AND DILATOR UNTIL THE SHEATH EXITED THE VESSEL, BUT THE DILATOR REMAINED IN THE VESSEL. THE PHYSICIAN INTERVENED TO CUT THE DILATOR HUB, THEN WITHDREW THE CLOTTRIEVER SHEATH FROM THE ACCESS SITE. USING A 14 FR SHEATH, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DILATOR FROM THE PATIENT WITHOUT DAMAGING THE VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7083936 ↗