Triever 24 22-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00850291007185), received between Mar 10, 2020 and Nov 25, 2025 — classified as 20 deaths, 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A 75-YEAR-OLD MALE UNDERWENT PULMONARY EMBOLISM (PE) THROMBECTOMY. THE PATIENT HAD SPINE SURGERY TWO DAYS BEFORE THE THROMBECTOMY AND THE PATIENT WAS SCHEDULED TO HAVE A MASS REMOVED THE DAY FOLLOWING THE THROMBECTOMY. AFTER ACCESSING THE RIGHT SIDE, THE MEDICAL TEAM HAD TROUBLE KEEPING THE WIRE PLACEMENT ON THE RIGHT SIDE AS THE PATIENT'S PULMONARY ARTERIES WERE ENLARGED. THE TRIEVER24 CATHETER (T24) FLIPPED WHEN THE DILATOR WAS REMOVED BEFORE THE FIRST RIGHT SIDE ASPIRATIONS. THE CATHETER WAS ADJUSTED TO THE CORRECT PLACEMENT AND THE PROCEDURE CONTINUED. BEFORE THE THIRD ASPIRATION, THE CATHETER WAS ADVANCED WITH THE TIP OF THE GUIDEWIRE OUTSIDE OF THE CATHETER. THE PATIENT'S PRESSURES STARTED TO DROP, AND THE PATIENT WAS ADMINISTERED VASOPRESSORS. THE PATIENT WAS THEN INTUBATED AND A CODE BLUE WAS CALLED. THE PATIENT HAD HIS CHEST CRACKED AND A SMALL PERFORATION WAS NOTED. THE PATIENT WAS EVENTUALLY STABILIZED AND WAS LATER DISCHARGED HOME.

  Patient problems: Great Vessel Perforation

  MAUDE report 23647159 ↗
• DeathSep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ARRIVED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND MILD CHEST PAIN. A COMPUTED TOMOGRAPHY SCAN REVEALED SIGNIFICANT CLOT BURDEN IN THE RIGHT PULMONARY ARTERY (RPA) AND LEFT PULMONARY ARTERY (LPA) WITH A LARGE SADDLE EMBOLUS. ACCESS WAS OBTAINED AND WIRE POSITIONING WAS ACHIEVED. THE TRIEVER24 WAS THEN INSERTED INTO THE RPA WITH THE DILATOR IN PLACE. THE PATIENT THEN SHORTLY BEGAN TO RAISE HER ARM IN DISCOMFORT. NO ASPIRATIONS WERE PERFORMED BUT THE PATIENT BEGAN TO DECOMPENSATE. A CODE WAS CALLED, AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE PATIENT REGAINED A PULSE AND NORMAL BREATHING. THE PATIENT CODED AGAIN AND EXPIRED AFTER UNSUCCESSFUL RESUSCITATION EFFORTS.

  Patient problems: Pulmonary Embolism

  MAUDE report 23089828 ↗
• DeathSep 3, 2025Use of Device Problem; Use of Device Problem

  A 61-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. IMAGING WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISM (PE) WITH HEAVY CLOT BURDEN ON BOTH SIDES. CLOT WAS ALSO OBSERVED IN THE ILIAC AND INFERIOR VENA CAVA. ACCESS AND WIRE POSITIONING WAS ACHIEVED WITHOUT ISSUE. THE ACCESS SHEATH WAS SWAPPED OUT FOR THE INTRI24 SHEATH. AFTER REMOVING THE DILATOR, THE TRIEVER24 (T24) WAS ADVANCED INTO PLACE. ASPIRATIONS WERE PERFORMED BUT YIELDED LITTLE TO NO CLOT. CAVITATION ALSO OCCURRED SO THE PHYSICIAN PULLED BACK THE T24 UNTIL IT FILLED. THIS OCCURRED WHEN THE TIP OF THE T24 WAS IN THE MAIN PULMONARY ARTERY. WHEN THIS OCCURRED, THE PATIENT BEGAN TO COUGH AND EXPERIENCED A SMALL AMOUNT OF HEMOPTYSIS. THE PHYSICIAN ADVANCED THE T24 FORWARD WITHOUT A DILATOR TO TAKE AN ANGIOGRAM. NO SIGNS OF PERFORATION WERE SEEN SO THE PROCEDURE CONTINUED. ASPIRATIONS WERE PERFORMED BUT CAVITATION OCCURRED AGAIN. WHEN PULLING THE T24 BACK, THE SYRINGE WAS FILLED WITH A "JELLO-LIKE" CLOT. AFTER ANOTHER ASPIRATION THE PATIENT BEGAN TO EXPERIENCE SEVERE HEMOPTYSIS. SIGNIFICANT CLOT BURDEN WAS OBSERVED IN THE SYRINGE. SUCTION WAS PERFORMED AND THE T24

  Patient problems: Great Vessel Perforation

  MAUDE report 22957420 ↗
• InjuryJun 19, 2025Use of Device Problem; Use of Device Problem

  A 66-YEAR-OLD MALE UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM TO ADDRESS THEIR PULMONARY EMBOLISM. THE MAJORITY OF CLOT WAS SUCCESSFULLY REMOVED WHEN THE PHYSICIAN USED THE TRIEVER20 CURVE (T20C) THROUGH THE TRIEVER24 (T24) TO DO A FINAL WALK BACK. THE T24 WAS POSITIONED IN THE LEFT PULMONARY ARTERY (LPA) WITH THE TIP JUST BEFORE THE CURVE OF THE LPA. THE T20C CAVITATED ON THE FINAL PULL AND WAS PULLED BACK INTO THE T24. AS THE T20C REACHED THE INFERIOR VENA CAVA, THE T24 WAS NOW OVER THE "HUMP" OF THE LPA. THE T24 WAS PULLED BACK INTO THE MAIN PULMONARY ARTERY AND IMAGING WAS PERFORMED. NO PERFORATION OR EXTRAVASATION WAS OBSERVED BUT THE PATIENT'S HEART RATE JUMPED UP TO 122. THIS WAS FOLLOWED BY A FLUCTUATION IN BLOOD PRESSURE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A HEMOPERICARDIUM. A DRAIN WAS PLACED WHERE 850 CC OF BLOOD WAS REMOVED BUT BLOOD WAS STILL COLLECTING IN THE HEART. A TAMPONADE WAS PERFORMED, AND THE PATIENT WAS TRANSFERRED TO A SISTER FACILITY. THE PATIENT WAS LAST REPORTED TO BE STABLE AND DOING OKAY.

  Patient problems: Great Vessel Perforation

  MAUDE report 22294368 ↗
• DeathOct 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT PRESENTED WITH AN INTERMEDIATE HIGH RISK SADDLE PULMONARY EMBOLISM. THEY HAD SYMPTOMS FOR ONE DAY PRIOR TO ADMISSION AND WERE STABLE BUT PRE-SYNCOPY. THE PROCEDURE BEGAN WITH MICRO-PUNCTURE IN THE RIGHT FEMORAL, DILATION AND INTRODUCTION OF THE INTRI24 SHEATH, THEN CROSSING THE RIGHT HEART WITH A FULLY FORMED PIGTAIL. PA PRESSURE MEASUREMENTS WERE TAKEN AND HEPARIN WAS ADMINISTERED AS THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS BELOW THERAPEUTIC LEVELS; THEN INTRODUCTION OF THE AMPLATZ GUIDEWIRE AND TRIEVER24 WITH ASPIRATIONS ON THE RIGHT SIDE. THE TRIEVER20 CURVE, WAS ALSO USED ON THE RIGHT WITH 5 ASPIRATIONS. THIS WAS FOLLOWED BY USING FLOWTRIEVER XL DISKS AND FT2 TO REMOVE A CHRONIC CLOT, AND AN ADDITIONAL 2 ASPIRATIONS. ALL THE BLOOD ASPIRATED WAS GIVEN BACK THROUGH FLOWSAVER. ONE HOUR INTO THE PROCEDURE THE PHYSICIAN WANTED TO GO TO THE LEFT PULMONARY ARTERY, WHEN BLOOD WAS OBSERVED ON THE FLOOR AND TABLE. THE PATIENT LOST A LOT OF BLOOD IN SECONDS, PROBABLY THROUGH THE OPEN SIDE PORT VALVE OF THE INTRI24 SHEATH. THE PATIENT WENT INTO CARDIAC ARREST BECAUSE OF SEVERE BLOOD LOSS. AFTER CPR AND BLOOD TRANSFUSION THEY WANTED TO CONTINUE THE THROMBECTOMY, BUT THE P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20375355 ↗
• MalfunctionAug 23, 2024Material Separation; Material Separation

  ON JULY 23, 2024, A PATIENT WITH PULMONARY EMBOLISM (PE) UNDERWENT PE THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE TREIVER24 (T24) CATHETER WAS USED TO ASPIRATE CLOT FROM THE PATIENT'S LUNGS. DURING ONE ASPIRATION IN THE LEFT PULMONARY ARTERY, THE DISTAL MARKER BAND DETACHED FROM THE CATHETER BUT REMAINED ON THE GUIDEWIRE. THE PHYSICIAN SUCCESSFULLY ASPIRATED THE MARKER BAND THOUGH THE T24. THE PROCEDURE WAS COMPLETED WITH APPROXIMATELY 95% OF THROMBUS REMOVED. POSTOPERATIVELY, THE PATIENT WAS DOING VERY WELL WITH SIGNIFICANT HEMODYNAMIC IMPROVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053156 ↗
• DeathJul 26, 2024Use of Device Problem; Use of Device Problem

  A 72-YEAR-OLD MALE WITH INTERMEDIATE HIGH-RISK PULMONARY EMBOLISM (PE) UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF DYSPNEA. THE PATIENT WAS TREATED WITH ANTICOAGULATION FOR A DAY PRIOR TO THE PROCEDURE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED WHICH REVEALED LARGE THROMBUS FORMATIONS IN THE LEFT AND RIGHT PULMONARY ARTERIES. THE PATIENT ALSO HAD ELEVATED TROPONIN LEVELS WITH AN ENLARGED RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). ADDITIONALLY, THE PATIENT'S RIGHT VENTRICLE/LEFT VENTRICLE RATIO WAS LARGER THAN 1.4. THE PROCEDURE BEGAN WITH ACCESS GAINED FROM THE RIGHT COMMON FEMORAL VEIN. OBTAINING WIRE POSITIONING WAS DIFFICULT DUE TO THE PATIENT'S ENLARGED RV AND RA, BUT EVENTUALLY AN AMPLATZ SUPER STIFF GUIDEWIRE WAS PLACED IN A DEEP POSITION. THERE WAS NO SLACK IN THE RV, SO A TRIEVER16 (T16) WAS USED TO STABILIZE A TRIEVER24 (T24) AND ADVANCE IT TO THE RV. AN INITIAL ASPIRATION WAS PERFORMED WITH THE T16 WHICH REMOVED SOME UNORGANIZED CLOT. THE T16 WAS REMOVED, AND A TRIEVER20 CURVE (T20C) WAS USED TO ASPIRATE MORE THROMBUS IN THE RIGHT INTERLOBAR ARTERY. THIS RESULTED IN THE PATIENT EXPERIEN

  Patient problems: Cardiac Arrest; Great Vessel Perforation; Hypoxia

  MAUDE report 19843047 ↗
• DeathJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 64-YEAR-OLD MALE PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH AND AN EPISODE OF PRESYNCOPE. IMAGING WAS PERFORMED WHICH REVEALED A PULMONARY EMBOLISM, POSITIVE BIOMARKERS, AND EVIDENCE OF RIGHT HEART STRAIN. AFTER A CONSULTATION, IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM. THE PROCEDURE BEGAN WITHOUT ISSUE AND WIRE POSITIONING WAS OBTAINED. AN ACTIVATED CLOTTING TIME (ACT) TEST WAS PERFORMED WHICH RESULTED IN A VALUE OF 127. THIS LED TO AN ADJUSTMENT AND INCREASE IN ANTICOAGULATION TO REACH THE GOAL OF ACT 250-300. THE TRIEVER24 (T24) WAS ADVANCED INTO THE MID BASAL BRANCH AND AN ASPIRATION WAS PERFORMED. THIS RESULTED IN CAVITATION AND AN ADDITIONAL VACUUM WAS APPLIED. WHILE MAINTAINING WIRE POSITIONING, THE T24 WAS WALKED BACK AND SLOWLY FILLED. NO THROMBUS WAS SEEN. THE FLOWSAVER WAS USED, AND A SECOND ATTEMPT WAS MADE TO ASPIRATE. THIS ALSO RESULTED IN CAVITATION. CONTRAST WAS INJECTED TO VISUALIZE THE THROMBUS. A LARGE THROMBUS WAS OBSERVED ON THE TIP OF THE T24 OUTSIDE OF THE SHEATH. THE DECISION WAS MADE TO USE FLOWTRIEVER XL DISCS TO PREVENT RE-EMBOLISM BUT BEFORE THEY WOULD BE INSERTED, THE PHYSICIAN REMO

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Pulmonary Embolism

  MAUDE report 19715427 ↗
• MalfunctionJul 1, 2024Material Separation; Material Separation

  A 20-YEAR-OLD FEMALE PATIENT WITH PULMONARY EMBOLISM (PE) AND CONCOMITANT DEEP VEIN THROMBOSIS (DVT), BEING TREATED WITH ANTICOAGULATION, UNDERWENT PE THROMBECTOMY WITH INARI DEVICES ON (B)(6) 2024. THE PE CLOT AGE WAS ESTIMATED AT 28 DAYS. DURING THROMBECTOMY, THE MEDICAL TEAM NOTICED THE FLOWTRIEVER 2 CATHETER (FT2) CAUGHT ON THE MARKER BAND OF THE TREIVER24 (T24,) THEN WHILE PULLING THE T24 BACK, THE MARKER BAND SEPARATED FROM THE T24 CATHETER AND REMAINED IN THE PATIENT'S INFERIOR VENA CAVA (IVC), STILL ON THE GUIDEWIRE. THE MARKER BAND WAS ASPIRATED AND RETRIEVED WITH A NEWLY OPENED T24 DEVICE. THE REMOVAL OF THE MARKER BAND PROLONGED THE SURGERY BY AN ADDITIONAL TEN MINUTES. THE CASE WAS CONCLUDED. THERE WAS NO RESULTING PATIENT INJURY. POSTOPERATIVELY, THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647191 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND UNDERWENT A CT ANGIOGRAM WHICH IDENTIFIED A LEFT-SIDED PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT) IN HER RIGHT ILIAC VEIN. THE PATIENT WAS SCHEDULED FOR A PE THROMBECTOMY WITH THE INARI FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM ON (B)(6) 2024. THE CLOT AGE WAS ESTIMATED AT 2 DAYS. THE SURGICAL PLAN WAS TO ADDRESS THE PE FIRST AND SCHEDULE A SUBSEQUENT PROCEDURE TO ADDRESS THE DVT. DUE TO THE DVT IN THE RIGHT LOWER EXTREMITY, ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL VEIN. WIRE POSITIONING WAS OBTAINED AND THE INARI TRIEVER24 (T24) WAS ADVANCED. HOWEVER, THE T24 WAS SLIGHTLY CAUGHT AT THE VALVE SO IT WAS REMOVED AND AN 8 X 40 BALLOON WAS USED TO NAVIGATE SMOOTHLY THROUGH THE VALVE. THE T24 WAS THEN ADVANCED INTO THE LEFT PULMONARY ARTERY (LPA) AND SEVERAL ASPIRATIONS WERE PERFORMED WHICH REMOVED THE THROMBUS. THE PHYSICIAN THEN ATTEMPTED TO REMOVE CLOT FROM THE TRUNCUS ANTERIOR ON THE RIGHT. AS THE PHYSICIAN MANIPULATED A 125 CM CATHETER THROUGH THE T24, THE PATIENT REPORTED NOT FEELING WELL AND EXPERIENCING BACK PAIN. THE PATIENT'S HEART RATE AND BLOOD PRESSURE DECREASED AND A CODE WAS INITIATED. A PE

  Patient problems: Bradycardia; Cardiac Perforation; Cardiogenic Shock; Intraoperative Pain; Low Blood Pressure/ Hypotension; Malaise; Pericardial Effusion

  MAUDE report 18907807 ↗
• InjuryFeb 16, 2024Entrapment of Device; Material Separation; Deformation Due to Compressive Stress; Entrapment of Device; Material Separation; Deformation Due to Compressive Stress

  AN 80-YEAR-OLD MALE PATIENT WITH A PREEXISTING PULMONARY EMBOLISM (PE) IN THE RIGHT PULMONARY ARTERY (RPA) UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM ON (B)(6), 2024. THE CLOT AGE WAS ESTIMATED AT 14 DAYS. THE HOSPITAL DID NOT HAVE AN INTRODUCER SHEATH AVAILABLE, SO THE TRIEVER24 (T24) WAS INSERTED WITHOUT THE RECOMMENDED 24 FR INTRODUCER SHEATH. DURING INSERTION THE DILATOR RETRACTED SLIGHTLY RESULTING IN SOME BUCKLING OF THE CATHETER. ADDITIONAL KINKING OF THE CATHETER WAS OBSERVED WHEN ADVANCING TO THE RPA, HOWEVER, IT DID NOT PREVENT THE DEVICE FROM ASPIRATING. THE PHYSICIAN WAS UNABLE TO REMOVE ANY CLOT AND ELECTED TO ABORT THE CASE WHEN THE PATIENT REPORTED EXPERIENCING DISCOMFORT. UPON REMOVAL OF THE T24 THE DISTAL SECTION OF THE T24 CATHETER SEPARATED FROM THE MAIN CATHETER BODY. THE DISTAL SECTION REMAINED IN THE RIGHT FEMORAL ARTERY, BUT THE PHYSICIAN WAS ABLE TO REMOVE IT WITHOUT SURGICAL INTERVENTION. ONCE REMOVED FROM THE PATIENT, IT WAS APPARENT THAT THE INTERNAL BRAIDING HAD BECOME UNCOILED. BOTH PORTIONS OF THE DEVICE WERE REMOVED FROM THE VESSEL WITHOUT INCIDENT AND THERE WAS NO RESULTING PATIENT INJURY OR VESSEL DAMAGE. THE PATIENT WAS REPORTED TO

  Patient problems: Discomfort

  MAUDE report 18728107 ↗
• InjuryFeb 16, 2024Entrapment of Device; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Entrapment of Device; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  A 71-YEAR-OLD FEMALE PATIENT WITH A PREEXISTING PULMONARY EMBOLISM (PE) WAS REFERRED FROM THE INTENSIVE CARE UNIT AND UNDERWENT A THROMBECTOMY WITH THE FLOWTRIEVER SYSTEM ON (B)(6) 2024. WHEN INSERTING THE TRIEVER24 (T24) CATHETER THROUGH THE INTRI24 INTRODUCER SHEATH THE PHYSICIAN DID NOT FULLY OPEN THE SHEATH SEPTUM, WHICH RESULTED IN KINKING OF THE CATHETER. SOME ADDITIONAL KINKING OF THE CATHETER WAS OBSERVED WHILE ADVANCING TO THE TARGET CLOT LOCATION. DESPITE THE CATHETER DAMAGE 80% OF THE CLOT WAS SUCCESSFULLY REMOVED. AT THE END OF THE PROCEDURE, THE PHYSICIAN EXPERIENCED SIGNIFICANT RESISTANCE WHILE ATTEMPTING TO RETRACT THE TRIEVER24 (T24) FROM THE INTRI24 SHEATH. FORCEFUL PULLING RESULTED IN PARTIAL REMOVAL OF THE T24 BUT THE T24 BECAME HEAVILY DAMAGED EXPOSING INTERNAL WIRE FROM THE BRAIDING. THE T24 WAS REMOVED THROUGH THE SHEATH AND THE INTRI24 WAS REMOVED AND CUT OPEN WITH SCISSORS BUT THE UPPER PORTION OF THE T24 REMAINED LODGED IN THE SHEATH SHAFT. BOTH PORTIONS OF THE T24 WERE REMOVED FROM THE PATIENT SUCCESSFULLY AND THERE WAS NO RESULTING VESSEL PERFORATION. THE INARI REPRESENTATIVE FOLLOWED UP WITH THE PHYSICIAN THE FOLLOWING DAY AND CONFIRMED THE PATIENT WAS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18718444 ↗
• DeathJan 18, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN 85-YEAR-OLD MALE PATIENT WITH PULMONARY EMBOLISM (PE) WAS ADMITTED TO THE HOSPITAL DUE TO WORSENING DYSPNEA. THE CLOT AGE WAS ESTIMATED AT 5 DAYS, BUT MAY HAVE BEEN CHRONIC. THE MEDICAL HISTORY INCLUDED DEEP VEIN THROMBOSIS (DVT) AND BRAIN BLEED DUE TO LONG-TERM ANTICOAGULATION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL IN WHICH A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) WAS PERFORMED. THIS REVEALED EVIDENCE OF RIGHT HEART STRAIN, MODERATE SEGMENTAL CLOT IN THE RIGHT, AND CENTRALLY OCCLUSIVE CLOT IN THE LEFT INTERLOBAR/LOWER LOBE. THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY USING THE INARI FLOWTRIEVER SYSTEM. ACCESS WAS OBTAINED AND CONTRAST WAS INJECTED WHICH REVEALED THE LEFT LOWER LOBE WAS COMPLETELY OCCLUDED. THE PROCEDURE BEGAN ON THE LEFT SIDE AND WIRE POSITIONING WAS OBTAINED. THE TRIEVER24 (T24) WAS ADVANCED TO THE PROXIMAL INTERLOBAR, AND 2 ASPIRATIONS WERE PERFORMED, HOWEVER, NO CLOT WAS RETRIEVED. A GLIDEWIRE WAS USED DISTALLY AND A TRIEVER20 CURVE (T20C) WAS TELESCOPED THROUGH THE T24; ASPIRATION YIELDED ACUTE CLOT. THE NEXT ASPIRATION CAVITATED IN WHICH A SECOND VACUUM WAS APPLIED. THE CATHETER WAS WALKED BACK WHEN THE SYRINGE FILLED NEAR THE PROXIMAL LEFT PULMONA

  Patient problems: Cardiac Arrest; Extravasation; Great Vessel Perforation; Hemoptysis; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 18532291 ↗
• InjuryJan 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A MALE PATIENT IN HIS EARLY 70S WITH A PULMONARY EMBOLISM (PE) UNDERWENT A THROMBECTOMY ON (B)(6) 2023 USING THE INARI FLOWTRIEVER SYSTEM. THE PROCEDURE WAS SUCCESSFUL, BUT IT WAS NOTED THAT THERE WAS DIFFICULTY ADVANCING THE TRIEVER24 AND TRIEVER16 INTO THE PULMONARY ARTERY. POSTOPERATIVELY, A COMPUTED TOMOGRAPHY SCAN REVEALED A PSEUDOANEURYSM IN THE RIGHT VENTRICLE. A WALL-ADHERENT CLOT-IN-TRANSIT (CIT) WAS ALSO OBSERVED. A SECOND THROMBECTOMY WAS ATTEMPTED ON (B)(6) 2023 WITH THE INARI FLOW TRIEVER, BUT THE CIT WAS UNABLE TO BE ASPIRATED. THE CIT WAS REMOVED SURGICALLY, AND THE PSEUDOANEURYSM WAS LIGATURED DURING THE SAME OPERATION.

  Patient problems: Pseudoaneurysm; Thromboembolism

  MAUDE report 18509280 ↗
• DeathDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 86-YEAR-OLD MALE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO ADDRESS THROMBUS THAT WAS ADHERENT TO A PACEMAKER LEAD. PRIOR TO ACCESS, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS USED TO VISUALIZE THE MASS. THE PROCEDURE BEGAN WITHOUT ISSUE AND WIRE POSITIONING WAS SUCCESSFULLY OBTAINED. THE INARI TRIEVER24 (T24) WAS ADVANCED INTO PLACE AND A TOTAL OF 5 ASPIRATIONS WERE PERFORMED WHICH YIELDED NO CLOT. THE PHYSICIAN ELECTED TO RE-WIRE INTO THE PULMONARY ARTERIES AND THE T24 WAS RE-INTRODUCED. AN ASPIRATION WAS PERFORMED, BUT NO CLOT WAS RETRIEVED. A SECOND ASPIRATION WAS PERFORMED WHICH YIELDED THE SAME RESULT. AT THIS POINT, THE TEE REVEALED THAT THE MASS APPEARED DIFFERENT THAN IN PRIOR IMAGES INDICATING A PULMONARY EMBOLISM. THE PATIENT'S OXYGENATION SATURATION DECREASED RAPIDLY (50-60% RANGE), AND THE PATIENT'S CARDIAC ACTIVITY DECLINED. A CODE WAS INITIATED AND CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED ALONG WITH ADDITIONAL LIFE-SAVING MEASURES. THE PATIENT WAS INTUBATED, AND IMAGING WAS ATTEMPTED TO IDENTIFY THE LOCATION OF THE MASS. UNFORTUNATELY, THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS DUE TO DIFFICULTY CROSSING THE HEART. EVENTUALLY A MIV CATHETER WAS PLACED IN T

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

  MAUDE report 18332419 ↗
• DeathNov 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR TREATMENT OF A BILATERAL CENTRAL PULMONARY EMBOLISM (PE) WITH POSITIVE BIOMARKERS AND RIGHT HEART STRAIN. THE PATIENT DETERIORATED SLIGHTLY UNDER MEDICAL ANTICOAGULATION THERAPY; DUE TO HER MEDICAL HISTORY IT BECAME APPARENT THAT THE CLOT WAS GREATER THAN 10 DAYS OLD AND THROMBOLYTICS MAY NOT BE EFFECTIVE. THE DECISION WAS MADE TO PERFORM A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM. THE PATIENT WAS STABLE UPON ARRIVAL AT THE CARDIAC CATHETERIZATION LAB. WIRE POSITIONING WAS OBTAINED IN THE LEFT PULMONARY ARTERY AND THE TRIEVER24 (T24) CATHETER WAS ADVANCED WITHOUT ISSUE. THE FIRST AND SECOND ASPIRATIONS FILLED THE SYRINGE SLOWLY AND STEADILY, BUT NO CLOT WAS OBSERVED. DURING THE THIRD ASPIRATION THE DOUBLE VACUUM TECHNIQUE WAS USED AND THE T24 WAS REPOSITIONED INTO THE LEFT MAIN TRUNK AND THE SYRINGE FILLED RAPIDLY, BUT AGAIN NO CLOT WAS RETRIEVED. THE DECISION WAS MADE TO ADVANCE THE T24 WITH THE DILATOR AND PERFORM ANOTHER ASPIRATION IN THE INTERLOBAR ARTERY. WHEN THE T24 WAS ADVANCED, THE PATIENT'S BLOOD PRESSURE DECREASED BELOW 100 MMHG (SYSTOLIC) FOR APPROXIMATELY 15 SECONDS BEFORE IMPROVING. THE FIRST AND SECO

  Patient problems: Cardiac Perforation; Chest Pain; Hemoptysis; Low Blood Pressure/ Hypotension

  MAUDE report 18088363 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD FEMALE PATIENT WITH A COMPLEX MEDICAL HISTORY (DESCRIBED IN B7) HAD BEEN EXPERIENCING SHORTNESS OF BREATH FOR 2 WEEKS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED PULMONARY EMBOLISM (PE) AND THE CLOT AGE WAS ESTIMATED AT 2 WEEKS. A THROMBECTOMY WAS PERFORMED WITH THE INARI FLOWTRIEVER SYSTEM TO ADDRESS THE PE. AFTER WIRE POSITIONING WAS OBTAINED, TWO ASPIRATIONS WERE PERFORMED WITH THE TRIEVER24 (T24) CATHETER WHICH YIELDED VERY CHRONIC AND SUBSTANTIAL CLOT. THE PHYSICIAN THEN ATTEMPTED TO RE-WIRE TO THE LEFT SIDE WITH THE AMPLATZ GUIDEWIRE, BUT NEEDED TO USE A J WIRE AND PENUMBRA 5F 130 CATHETER. WHEN THE T24 WAS UNABLE TO ADVANCE PAST THE MAIN PULMONARY ARTERY, THE TRIEVER16 (T16) CURVE WAS USED THROUGH THE T24. THE T16 WAS POINTED DOWN AT THE SUPER SEGMENT BRANCH LEVEL AND THERE WAS NO WIRE VISUALIZATION THROUGH THE T16 CATHETER. THE GUIDEWIRE WAS PULLED BACK AND THE AMPLATZ GUIDEWIRE WAS ADVANCED. HOWEVER, THE T16 CURVE WAS CURVED IN AN UNEXPECTED MANNER AND THE PHYSICIAN SUSPECTED THAT THE T16 MAY HAVE BEEN POSITIONED IN THE HEART. THE T24 AND T16 CATHETERS WERE PULLED BACK (TOGETHER) INTO THE MAIN PULMONARY ARTERY. IMAGING WAS PERFORMED IN WHICH CONTRAST DID NO

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade

  MAUDE report 17408429 ↗
• DeathJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 69-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN. A PULMONARY EMBOLISM (PE) AND LEFT LEG DEEP VEIN THROMBOSIS (DVT) WERE FOUND INCIDENTALLY. THE CLOT AGE WAS ESTIMATED AT 1 DAY. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED WHICH REVEALED THE CLOT WAS ALL LOCATED IN THE LEFT PULMONARY ARTERY (LPA); HOWEVER, THE PHYSICIAN SUSPECTED THAT THERE MAY ALSO BE CLOT PRESENT IN THE INFERIOR VENA CAVA (IVC). A THROMBECTOMY WAS PLANNED FOR THAT EVENING USING THE INARI FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM FOLLOWED BY PLACEMENT OF AN IVC FILTER. LOCAL ANESTHESIA WITH SEDATION WAS ADMINISTERED AND A MICRO PUNCTURE NEEDLE WAS USED TO GAIN ACCESS TO THE RIGHT FEMORAL VEIN. AN 8 FR SHEATH WAS INSERTED AND FOLLOWED WITH A BENTSON GUIDEWIRE AND PIGTAIL CATHETER, CROSSING THE HEART AND POSITIONING THE PIGTAIL CATHETER AND BENTSON GUIDEWIRE IN THE LPA. THE BENTSON WAS THEN EXCHANGED WITH A 1 CM AMPLATZ 260 GUIDEWIRE. THE INARI INTRI24 INTRODUCER SHEATH WAS INSERTED INTO THE LPA WITH NO CHALLENGES AND A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED, CONFIRMING THE CLOT EXTENDED FROM THE LPA INTO THE IVC. WIRE POSITIONING WAS ACHIEVED AND THE INARI T

  Patient problems: Cardiac Perforation; Distress; Hemoptysis; Intraoperative Pain

  MAUDE report 17379735 ↗
• DeathMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE IN HER EARLY 60S PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND THE CT ANGIOGRAM (CTA) REVEALED A DIAGNOSIS OF BILATERAL PULMONARY EMBOLISM (PE). THE PATIENT DID NOT IMPROVE WITH THROMBOLYTIC MEDICAL THERAPY (TPA) AND UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM ON (B)(6), 2023. LOCAL ANESTHESIA WITH SEDATION AND HEPARIN WERE ADMINISTERED. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL VEIN USING THE INARI INTRI24 SHEATH AND THE AMPLATZ SUPER STIFF GUIDEWIRE WAS USED TO OBTAIN WIRE POSITION. WHILE ASPIRATING, THE CLOT BECAME LODGED IN THE TIP OF THE TRIEVER24 (T24) CATHETER. DUE TO THE LARGE CLOT SIZE, IT WOULD NOT ASPIRATE THROUGH THE T24 AND WAS PULLED INTO THE INFERIOR VENA CAVA (IVC). THE FLOWTRIEVER XL DISKS WERE PLACED FROM THE LEFT GROIN, ABOVE THE CLOT, AND THE FLOWTRIEVER2 WAS USED IN CONJUNCTION WITH THE T24 TO REMOVE A SIGNIFICANT AMOUNT OF CLOT. THE CLOTTRIEVER CATHETER WAS THEN USED TO ADDRESS THE REMAINING CLOT. HOWEVER, BASED ON CTA ANALYSIS, IT APPEARS THERE WERE MULTIPLE TIMES IN WHICH THE DISKS WERE NOT DEPLOYED DURING THE CLOT RETRIEVAL PROCESS. CLOT WAS THEN OBSERVED ON THE IVC ANGIOGRAM TO HAVE TR

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Embolism/Embolus

  MAUDE report 16916730 ↗
• DeathSep 6, 2022Use of Device Problem; Use of Device Problem

  A 73-YEAR-OLD FEMALE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT (ED) ON (B)(6) 2022 PRESENTING WITH SHORTNESS OF BREATH, CHEST PAIN, AND MILD SYNCOPE. THE PATIENT WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISM (PE) WHICH WAS CONFIRMED BY COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA). VISUAL ASSESSMENT OF RV/LV RATIO WAS ESTIMATED TO BE AT LEAST 1.20. CTA ALSO CONFIRMED RIGHT HEART STRAIN AND SIGNIFICANT CLOT BURDEN. THE BILATERAL PE WAS CONCENTRATED IN THE INTERLOBAR SEGMENT AND TRUNCUS ANTERIOR (TA) ON THE RIGHT SIDE AND SIMILAR INTERLOBAR THROMBUS ON THE LEFT SIDE. THE PATIENT WAS TREATED WITH HEPARIN OVERNIGHT AND SCHEDULED FOR A THROMBECTOMY WITH THE INARI TRIEVER24 ON (B)(6) 2022. THE PATIENT'S MEDICAL HISTORY INCLUDED A PE A FEW YEARS AGO FOLLOWING TOTAL KNEE REPLACEMENT SURGERY. AT THAT TIME, THE PATIENT WAS DISCHARGED FROM THE ED AND PRESCRIBED XARELTO FOR 90 DAYS WITHOUT SURGICAL INTERVENTION. THE PATIENT'S PREOPERATIVE VITAL SIGNS WERE AS FOLLOWS: HEART RATE (HR): 83 BPM; BLOOD PRESSURE (BP): 119/79 MMHG WITH THE HEAD OF THE BED ELEVATED 30°; SPO2: 96% ON 2L OF OXYGEN. THE PHYSICIAN GAINED ACCESS TO THE INTRAJUGULAR VIA MICRO PUNCTURE NEEDLE ACCESS UNDER ULTRASOUND GUIDANCE. LO

  Patient problems: Cardiac Arrest; Perforation of Vessels; Pericardial Effusion

  MAUDE report 15366770 ↗
• DeathJul 12, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 78-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL THE MORNING OF (B)(6) 2022 COMPLAINING OF CHEST PAIN AND SHORTNESS OF BREATH OVER THE LAST COUPLE OF DAYS. THE PATIENT TESTED POSITIVE FOR COVID AND THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED SIGNIFICANT CLOT BURDEN IN BOTH THE RIGHT AND LEFT PULMONARY ARTERY WITH AN INCREASED BURDEN ON THE RIGHT SIDE. THE PATIENT HAD AN ELEVATED RV/LV RATIO, ELEVATED BRAIN NATRIURETIC PEPTIDE (BNP) LEVELS, AND ELEVATED TROPONIN LEVELS. THE PATIENT WAS DIAGNOSED WITH A BILATERAL SADDLE PULMONARY EMBOLISM (PE) AND A THROMBECTOMY WAS SCHEDULED FOR LATER THAT NIGHT WITH THE INARI FLOWTRIEVER. THE BEGINNING OF THE CASE WAS UNEVENTFUL AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY OBTAIN WIRE POSITIONING BY CROSSING THE HEART WITH A FULLY FORMED PIG CATHETER AND BENTSON WIRE. THE BENTSON WAS EXCHANGED FOR A 1 CM AMPLATZ SUPERSTIFF GUIDEWIRE. THE PHYSICIAN INTRODUCED THE TRIEVER24 (T24) INTO THE GORE DRYSEAL SHEATH (24 FR) AND ADVANCED THE T24 TO THE MAIN PULMONARY ARTERY. THE DECISION WAS MADE TO ADDRESS THE LEFT SIDE FIRST AND 4 ASPIRATIONS WERE PERFORMED IN THE LEFT PULMONARY ARTERY. CLOT WAS REMOVED, HOWEVER, THE CATHETER CAVITATED DURING 2 OF THE AS

  Patient problems: Bronchial Hemorrhage; Cardiac Arrest; Cough; Hemoptysis; Perforation of Vessels

  MAUDE report 14991993 ↗
• InjuryJun 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A 68-YEAR-OLD MALE PATIENT WITH A PULMONARY EMBOLISM UNDERWENT ATTEMPTED EMBOLECTOMY WITH THE INARI FLOWTRIEVER ON (B)(6) 2022. FOUR WEEKS PRIOR TO THE PROCEDURE, A CT ANGIOGRAM REVEALED A MASS ADHERING TO THE WALL IN THE MAIN RIGHT PULMONARY ARTERY (RPA) TOWARDS THE TRICUSPID ARTESIA (TA) AND UPPER LOBE. DURING THE PROCEDURE, 3 BIOPSY TISSUE SAMPLES WERE TAKEN TO DETERMINE THE NATURE OF THE MASS SINCE THE PATIENT HAD AN EXTENSIVE HISTORY OF RENAL CANCER. THE PATIENT WAS PLACED UNDER LOCAL ANESTHESIA WITH SEDATION AND GOOD, STABLE GUIDEWIRE POSITION WAS ACHIEVED IN THE TA. DUE TO INTRAJUGULAR ACCESS, THE CURVE IN THE WIRE WAS A BIT STEEP TOWARDS THE PULMONARY ARTERIES. THE PATIENT'S RIGHT VENTRICLE WAS NOT UNDER STRAIN AND THEREFORE SMALL, WHICH MADE THE CURVE EVEN STEEPER. PROPER DILATION OF THE ACCESS SITE WAS PERFORMED, AND THE GORE DRY SHEATH (GDS) WAS PLACED SUCCESSFULLY. THE TRIEVER24 (T24) WAS THEN INTRODUCED AND ADVANCED. THERE WAS DIFFICULTY ADVANCING THE T24 AT THE STEEP CURVE AND A DECISION WAS MADE TO EXCHANGE THE T24 WITH THE TRIEVER16. WHEN THE TRIEVER16 WAS BEING HANDED TO THE PHYSICIAN (PRIOR TO USE), THE PATIENT COMPLAINED OF PAIN IN THE STOMACH AREA AND COLLAPSED.

  Patient problems: Abdominal Pain; Cardiac Perforation; Pericardial Effusion

  MAUDE report 14721950 ↗
• DeathJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT IN HER EARLY 70S PRESENTED WITH DIFFICULTY BREATHING AND THE COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM REVEALED BILATERAL PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG. ON (B)(6) 2022, THE INARI TRIEVER24 (T24) WAS USED TO ATTEMPT TO REMOVE THE PE. THE PATIENT WAS GIVEN LOCAL ANESTHESIA WITH SEDATION AND SYSTEMIC HEPARIN. SEVEN (7) PASSES WERE MADE WITH THE T24, YIELDING APPROXIMATELY 70% OF THE CLOT BURDEN; HOWEVER, CATHETER CAVITATION WITH THE T24 OCCURRED TWICE DURING ASPIRATION ATTEMPTS. DURING THE PROCEDURE THE PATIENT EXPERIENCED A PARADOXICAL STROKE IN THE MAIN CORONARY ARTERY; A PATENT FORAMEN OVALE (PFO) WAS SUSPECTED. THE PATIENT WAS GIVEN COMFORT CARE AND DIED AROUND 3:00 AM ON (B)(6) 2022. ADDITIONAL INFORMATION WAS REQUESTED FROM THE INITIAL REPORTER ON SEVERAL OCCASIONS, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE.

  Patient problems: Low Oxygen Saturation; Stroke/CVA

  MAUDE report 14570532 ↗
• DeathMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PRESENTED WITH SHORTNESS OF BREATH AND WAS DIAGNOSED WITH A SUB-MASSIVE PULMONARY EMBOLISM (PE). THE PATIENT WAS IN STABLE CONDITION AND WAS FLOWN IN FROM A HOSPITAL AT HIGHER ELEVATION. A COMPUTERIZED TOMOGRAPHY (CT) SCAN FROM THE TRANSFERRING FACILITY REVEALED BILATERAL CLOT BEGINNING IN BOTH PULMONARY ARTERIES AND EXTENDING INFERIORLY INTO THE DISTAL BRANCHES OF THE LOWER LOBES. THE CLOT BURDEN IN THE LEFT LUNG WAS GREATER THAN THE RIGHT. THE CT SCAN ALSO REVEALED ENLARGED CENTRAL PULMONARY VASCULATURE OF THE LEFT PULMONARY ARTERY (LPA) AND RIGHT PULMONARY ARTERY (RPA) MEASURING ABOUT 4.5 CM, AN RV/LV RATIO OF 1.2, AND SLIGHT PERIPHERAL CALCIFICATION BILATERALLY. THE CLOT WAS ACUTE ON CHRONIC CLOT, AND THE TREATMENT PLAN WAS TO USE THE FLOWTRIEVER 24 (T24) TO ATTEMPT TO RETRIEVE THE CLOTS BEGINNING WITH THE ACUTE CLOT BLOCKING THE LPA THEN ADDRESSING THE RPA. AN ECHOCARDIOGRAM PERFORMED PRIOR TO THE PROCEDURE REVEALED ENLARGEMENT OF THE RIGHT HEART, BUT THE HEART WAS "PUMPING AS IT SHOULD AND NO OTHER SIGNIFICANT FINDINGS WERE DISCOVERED". THE PHYSICIAN EXPERIENCED DIFFICULTY ESTABLIS

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Tachycardia

  MAUDE report 13934466 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH COVID WAS IN THE INTENSIVE CARE UNIT AND SCHEDULED TO UNDERGO A THROMBECTOMY. COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED A PREEXISTING MASSIVE SADDLE PULMONARY EMBOLISM (PE) WITH BILATERAL CLOT BURDEN IN BOTH LUNGS. ON (B)(6) 2021 THE INARI TRIEVER 24 WAS USED TO TREAT THE PE. THE PROCEDURE WAS PERFORMED INDEPENDENTLY AND THE EVENT DESCRIBED BELOW WAS FIRST REPORTED TO INARI ON (B)(6) 2021. GENERAL ANESTHESIA WAS ADMINISTERED AND THE AMPLATZ SUPER STIFF 1 CM GUIDEWIRE WAS USED TO POSITION THE TRIEVER 24 (T24) IN THE RIGHT LUNG; SEVERAL ASPIRATIONS YIELDED SIGNIFICANT CLOT. AFTER THE RIGHT SIDE WAS CONFIRMED TO BE CLEAR OF CLOT, THE PHYSICIAN REPOSITIONED THE T24 TO THE LEFT LUNG. ONE ASPIRATION WAS ATTEMPTED ON THE LEFT SIDE, BUT DUE TO THE LARGE AMOUNT OF CLOT PRESENT, THE ENTIRE CLOT WAS UNABLE TO BE SUCTIONED INTO THE T24. THIS RESULTED IN A PORTION OF THE CLOT SUCTIONED INSIDE THE CATHETER AND THE REMAINING PORTION OUTSIDE OF THE T24. IN ORDER TO REMOVE THE CLOT, THE PHYSICIAN WALKED THE T24 BACK SLOWLY USING THE (T24) LARGE BORE SYRINGE TO PROVIDE VACUUM. WHEN TRYING TO PASS THE PULMONIC VALVE, THE T24 SYRINGE IMMEDIATELY FILLED WI

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

  MAUDE report 13057714 ↗