ZOOM Reperfusion CatheterRecalls & reported problems across all models

We found 6 models of ZOOM Reperfusion Catheter by Imperative Care, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2020 and May 26, 2023 — classified as 1 death, 17 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ZOOM Reperfusion Catheter problems

ZOOM Reperfusion Catheter models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ZOOM™ Reperfusion Catheter ICRC071137

  Catheter, Thrombus Retriever
  13 reports
• ZOOM™ Reperfusion Catheter ICRC071137

  Catheter, Thrombus Retriever
  1 death4 reports
• ZOOM™ Reperfusion Catheter ICRC045144

  Catheter, Thrombus Retriever
  3 reports
• ZOOM™ Reperfusion Catheter ICRC035158

  Catheter, Thrombus Retriever
  2 reports
• ZOOM™ Reperfusion Catheter ICRC055137

  Catheter, Thrombus Retriever
  2 reports
• ZOOM™ Reperfusion Catheter ICRC035158

  Catheter, Thrombus Retriever
  1 report

Recent ZOOM Reperfusion Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 60-YEAR-OLD MALE WAS TREATED FOR AN OCCLUSION THAT EXTENDED FROM THE BASILAR ARTERY TO THE LEFT POSTERIOR CEREBRAL ARTERY (PCA). ACCESS WAS OBTAINED WITH A ZOOM 88 ACCESS CATHETER OVER A GUIDE WIRE. A ZOOM 71 AND A THIRD PARTY MICROCATHETER WERE ADVANCED OVER A GUIDEWIRE THROUGH THE ZOOM 88. AFTER POSITIONING THE ZOOM 71, MICROCATHETER, AND GUIDEWIRE IN THE LEFT PCA, THE ZOOM 88 WAS ADVANCED TO THE LEFT PCA. THE GUIDEWIRE, THIRD PARTY MICROCATHETER, AND ZOOM 71 WERE THEN REMOVED FROM THE PATIENT AND ASPIRATION WAS APPLIED TO THE ZOOM 88 FOR APPROXIMATELY TWO MINUTES. THE CLOT IN THE BASILAR ARTERY WAS REMOVED; HOWEVER, THE PCA REMAINED OCCLUDED. A SECOND PASS WAS COMPLETED WITH A ZOOM 45 CATHETER, A THIRD PARTY MICROCATHETER, AND A GUIDEWIRE ADVANCED THROUGH THE SAME ZOOM 88 AND POSITIONED IN THE LEFT PCA. THE ZOOM 88 WAS THEN ADVANCED TO THE LEFT PCA. THE THIRD PARTY MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED. ASPIRATION WAS APPLIED FOR APPROXIMATELY TWO MINUTES TO THE ZOOM 45 AND ZOOM 88 CATHETERS, BUT NO CLOT WAS REMOVED. THE LEFT PCA REMAINED OCCLUDED. A THIRD PASS WITH THE SAME ZOOM 88, ZOOM 45, THIRD PARTY MICROCATHETER, AND GUIDEWIRE WAS COMPLETED. WHILE ADVANCING THE G

  Patient problems: Gastritis; Hernia; Perforation of Vessels

  MAUDE report 17014432 ↗
• InjuryMay 10, 2023Break; Material Separation; Break; Material Separation

  AN 83-YEAR-OLD PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE DISTAL PORTIONS OF THE M2 SEGMENT. THE PATIENT HAD A TYPE 3 ARCH, AND THE ANATOMY WAS REPORTED TO BE TORTUOUS. ACCESS WAS OBTAINED WITH A TRACSTAR ACCESS CATHETER WHICH WAS POSITIONED AT THE PETROUS CAVERNOUS OF THE INTERNAL CAROTID ARTERY (ICA). A ZOOM 55 CATHETER WAS ADVANCED THROUGH THE TRACSTAR TO THE FACE OF THE CLOT. A FIRST PASS WAS MADE WITH THE ZOOM 55 WITHOUT ANY ISSUES. FOR THE SECOND PASS, THE PHYSICIAN ADVANCED A THIRD PARTY MICROCATHETER AND STENT RETRIEVER THROUGH THE SAME ZOOM 55 TO THE CLOT. AFTER THE SECOND PASS, WHILE RETRACTING THE STENT RETRIEVER INTO THE ZOOM 55, THE DISTAL PORTION OF THE ZOOM 55 SHAFT DEFORMED AND BROKE APPROXIMATELY 12CM PROXIMAL FROM THE DISTAL END OF THE CATHETER. WITH THE STENT RETRIEVER ALREADY THROUGH THE ZOOM 55, THE PHYSICIAN SUCCESSFULLY REMOVED THE DISTAL SEGMENT OF THE ZOOM 55 AND STENT RETRIEVER TOGETHER. THE PHYSICIAN DID NOT CONTINUE WITH THE PROCEDURE. THE CLOT WAS PARTIALLY REMOVED, AND THE PATIENT ACHIEVED PARTIAL REPERFUSION WITH A TICI 2A SCORE. THE PATIENT WAS REPORTED STABLE, AND NO PATIENT SEQUELAE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908054 ↗
• InjuryFeb 21, 2023Break; Material Separation; Break; Material Separation

  A 66-YEAR-OLD FEMALE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE LEFT M2. A COMPETITOR'S BALLOON GUIDE CATHETER WAS ADVANCED AND PARKED AT THE PROXIMAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ADVANCED THE ZOOM 45 ASPIRATION CATHETER TO THE FACE OF THE CLOT. DURING CLOT RETRIEVAL ON THE FIRST PASS, THE PHYSICIAN FELT RESISTANCE ON THE ZOOM 45 WHILE PULLING IT BACK INSIDE THE GUIDE CATHETER. THE PHYSICIAN NOTICED A KINK IN THE COMPETITOR'S GUIDE CATHETER- APPROXIMATELY 15CM FROM THE DISTAL TIP. AFTER APPLYING MORE RETRIEVAL FORCE, THE PHYSICIAN FELT THE RESISTANCE GIVE WAY AND WAS ABLE TO REMOVE THE ZOOM 45 CATHETER FROM THE PATIENT. IN A FOLLOW-UP ANGIOGRAPHY THE PHYSICIAN NOTICED THAT A PORTION OF THE ZOOM 45 CATHETER WAS STILL IN THE PATIENT. THE LOCATION OF THE BREAK ON THE ZOOM 45 WAS NOT SPECIFIED. A SNARE WAS USED TO SUCCESSFULLY CAPTURE THE ZOOM 45 PIECE AND REMOVE IT FROM THE PATIENT'S BODY. FOLLOWING THE REMOVAL OF THE COMPETITOR BALLOON GUIDE CATHETER, THE PHYSICIAN PROCEEDED THE CASE WITH DIFFERENT COMPETITOR GUIDE CATHETER. HOWEVER, THE REPLACEMENT GUIDE CATHETER ALSO KINKED APPROXIMATELY 15CM FROM THE DISTAL TIP. THE PATIENT'S ANATO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414812 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE RIGHT INTERNAL CAROTID ARTERY (ICA) M2 SEGMENT. THE PATIENT HAD A HISTORY OF SEPTIC EMBOLI, "BAD" ENDOCARDITIS, AND WAS AN IV DRUG USER. ACCESS WAS OBTAINED USING A GUIDEWIRE, COMPETITOR GUIDE CATHETER AND COMPETITOR LARGE BORE CATHETER. THE PHYSICIAN STATED THAT HE HAD DIFFICULTY ADVANCING THE GUIDEWIRE BUT WAS SUBSEQUENTLY ABLE TO MAKE FIVE UNSUCCESSFUL PASSES WITH A COMBINATION OF COMPETITOR GUIDE CATHETER, STENT RETRIEVER AND ASPIRATION CATHETERS. A ZOOM 71 ASPIRATION CATHETER WAS NEXT ADVANCED TO THE VESSEL AND FLOW WAS RESTORED. SUBSEQUENTLY THE VESSEL SHUT DOWN WHICH WAS ATTRIBUTED TO A VESSEL DISSECTION. A STENT WAS THEN PLACED IN THE VESSEL AND FLOW WAS RESTORED. THE PATIENT WAS TRANSFERRED TO THE ICU WARD BECAUSE OF COMPLICATED ENDOCARDITIS.

  Patient problems: Vascular Dissection

  MAUDE report 14383101 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE RIGHT M2. FIRST, FOUR PASSES WERE CONDUCTED WITH TWO SIZES OF STENT RETRIEVERS AND COMPETITOR'S 5F AND 6F ASPIRATION CATHETERS. AFTER THE FOUR UNSUCCESSFUL ATTEMPTS TO OPEN THE OCCLUSION, A ZOOM 45 ASPIRATION CATHETER WAS SUCCESSFULLY USED TO REMOVE THE CLOT AND FLOW WAS RESTORED. THE PHYSICIAN OBSERVED A VESSEL DISSECTION DURING THE ROUTINE CONTRAST RUN PERFORMED POST CLOT REMOVAL. A STENT WAS THEN PLACED THROUGH THE VESSEL AND FLOW WAS CONFIRMED. THERE WERE NO DEVICE DEFICIENCIES REPORTED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED TO REHAB, AND THE STENT WAS REPORTEDLY OPEN.

  Patient problems: Vascular Dissection

  MAUDE report 14382925 ↗
• MalfunctionJan 7, 2022Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE SECONDARY TO AN AUTOMOBILE ACCIDENT. THE PATIENT WAS ALSO BEING TREATED FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) IN THE TARGET VESSEL FOR THROMBECTOMY (M1). A TOTAL OF THREE PASSES WERE MADE. AFTER THE FIRST PASS, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING ZOOM 71 THROUGH THE ICI ROTATING HEMOSTASIS VALVE (RHV). THE ENTIRE ZOOM 71 WAS REMOVED AND UPON OBSERVATION ON THE OPERATING TABLE, IT WAS NOTICED THE CATHETER SHAFT HAD FRACTURED. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THIS CATHETER. THE PHYSICIAN COMMENTED THE CATHETER WAS CAUGHT ON THE RHV WHICH WAS POSSIBLY NOT FULLY OPENED WHEN RETRACTING. THE DEVICE WAS REPLACED WITH ANOTHER ZOOM 71 AND SECOND PASS WAS PERFORMED WITHOUT ANY ISSUES. SECOND ZOOM 71 WAS REMOVED, AND THE PHYSICIAN MADE THE THIRD PASS USING ZOOM 55. THE CASE WAS COMPLETED WITH SUCCESSFUL REPERFUSION OF M1 SEGMENT. IN ADDITION, THE PATIENT WAS TREATED FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) WITH ANGIOPLASTY AND STENT. THE PATIENT WAS REPORTED AS STABLE. THERE WERE NO PATIENT SEQUALAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13198027 ↗
• MalfunctionDec 22, 2021Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BASILAR OCCLUSION. SINCE BOTH ILIAC ARTERIES WERE OCCLUDED, ACCESS WAS OBTAINED THROUGH THE LEFT RADIAL ARTERY. A SHARP BEND WAS NOTED OFF THE SUBCLAVIAN ARTERY. ZOOM 88 WAS ADVANCED TO THE DISTAL CERVICAL VERTEBRAL ARTERY WITHOUT ANY ISSUES. FIRST PASS WAS MADE SUCCESSFULLY USING ZOOM 71 OPENING THE BASILAR AND ONE POSTERIOR CEREBRAL ARTERY (PCA). DURING SECOND PASS ATTEMPT, RESISTANCE WAS NOTED WHEN ADVANCING THE SAME ZOOM 71 THROUGH THE ZOOM 88. ZOOM 71 WAS REMOVED AND THE PHYSICIAN DECIDED TO REPLACE IT WITH A COMPETITOR CATHETER. SINCE RESISTANCE WAS FELT WHEN ADVANCING THE COMPETITOR CATHETER, THE PHYSICIAN DECIDED TO END THE CASE WITHOUT COMPLETING THE PASS AS TICI 2B WAS ACHIEVED. SEVERAL DAYS LATER, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED A FOREIGN BODY IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT. THE PHYSICIAN REVIEWED THE IMAGING FROM THE CASE AND NOTICED A TIP. PER THE PHYSICIAN, IT IS UNKNOWN IF THE TIP WAS DETACHED FROM THE ZOOM OR THE COMPETITOR'S DEVICE. THERE WAS NO INTERVENTION PERFORMED AND NO PATIENT SEQUALAE REPORTED. NOTE THAT THERE WERE TWO VOLUNTARY MEDWATCH REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062084 ↗
• InjuryNov 24, 2021Entrapment of Device

  THE PATIENT REQUIRED AN ACUTE STROKE INTERVENTION SECONDARY TO AN OCCLUSION IN THE LEFT PROXIMAL BASILAR ARTERY. DURING THE PROCEDURE, A MINUTE CATHETER TIP FRAGMENT WAS EMBEDDED IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12871283 ↗
• InjuryNov 23, 2021Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION WITHIN THE RIGHT INTERNAL CAROTID ARTERY (ICA) TERMINUS AND MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. INTERVENTIONAL NEUROLOGIST ATTEMPTED SIX PASSES WITH A BALLOON GUIDE CATHETER, LARGE BORE ASPIRATION CATHETER (LBC), MICROCATHETER, REVASCULARIZATION CATHETER AND STENT RETRIEVER. SINCE THE OCCLUSION WAS NOT RESOLVED, THE PHYSICIAN DECIDED TO USE THE ZOOM SYSTEM. ACCESS WAS OBTAINED THROUGH THE LEFT GROIN WITH AN 8F SHUTTLE, A VTK SELECT CATHETER AND A 038 GUIDEWIRE. ZOOM 71 WAS ADVANCED TO THE CLOT OVER THE MICROCATHETER AND GUIDEWIRE. USING A 60CC SYRINGE, THE PHYSICIAN APPLIED ASPIRATION. THE PHYSICIAN THEN TRIED TO ADVANCE ZOOM 88 TO THE CLOT, BUT IT COULD NOT PASS THE PATIENT'S OPHTHALMIC ARTERY. HE TRIED ROTATING ZOOM 88 TO CHANGE THE ORIENTATION OF THE TIP BUT WAS UNSUCCESSFUL. THE ZOOM71 WAS THEN USED TO PERFORM THE THROMBECTOMY. WHEN HE TRIED TO RETRACT THE ZOOM71, HE NOTICED THAT THERE WAS NO ONE-TO-ONE MOVEMENT (AS THE PHYSICIAN WAS PULLING BACK THE PROXIMAL END THE CATHETER WAS MOVING OUTSIDE THE PATIENT, BUT HE DIDN'T NOT SEE DISTAL CATHETER MOVEMENT ON ANGIOGRAPHY). HE OBSERVED THAT THE ZOOM71 CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865768 ↗
• MalfunctionNov 19, 2021Material Fragmentation

  THE PATIENT REQUIRED AN ACUTE STROKE INTERVENTION SECONDARY TO AN OCCLUSION IN THE LEFT PROXIMAL BASILAR ARTERY. DURING THE PROCEDURE, A MINUTE CATHETER TIP FRAGMENT WAS EMBEDDED IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12845547 ↗
• InjuryJul 14, 2021Break; Break

  PATIENT PRESENTED WITH RIGHT M1 OCCLUSION. PHYSICIAN ACCESSED THE RIGHT FEMORAL WITH ACCESS CATHETER. THE ACCESS CATHETER WAS NAVIGATED TO THE RIGHT INTERNAL ARTERY JUST DISTAL TO THE BIFURCATION OF THE EXTERNAL OVER A 5FR SELECT CATHETER AND A .035 GUIDEWIRE (GW). THE SELECT CATHETER AND 0.035" GW WERE REMOVED. 0.014" GW, ZOOM 71 AND A 0.017" MICROCATHETER (MC) WERE ADVANCED TO THE CAVERNOUS CAROTID SEGMENT OF THE RIGHT ICA. THE MC AND GW WERE ADVANCED TO THE DISTAL MCA TERRITORY AND THE ZOOM 71 WAS ADVANCED TO THE M1 SEGMENT JUST PROXIMAL TO THE CLOT. A STENT RETRIEVER WAS ADVANCED THROUGH THE EMPTY MC TO THE LOCATION OF THE CLOT AND DEPLOYED. ASPIRATION WAS STARTED AND IT WAS NOTED THAT THE ZOOM 71 WAS NOT CORKED. AFTER A FEW MINUTES THE STENT RETRIEVER AND ZOOM 71 WERE REMOVED FROM THE PATIENT AND CLOT WAS NOTED ON THE STENT RETRIEVER. FOR THE SECOND PASS, THE 0.14 " GW, MC AND ZOOM 71 WERE RE-INTRODUCED INTO THE ACCESS CATHETER AND NAVIGATED TO THE CAVERNOUS CAROTID SEGMENT OF THE ICA. THE GW AND MC WERE THEN NAVIGATED TO THE DISTAL MCA TERRITORY AND THE ZOOM 71 WAS ADVANCED TO THE M1 SEGMENT. DURING THIS ADVANCEMENT PHYSICIAN MENTIONED HAVING DIFFICULTY ADVANCING THE ZOOM 71

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170727 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH AN M3 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. ACCESS WAS OBTAINED WITH A COMPETITOR ACCESS CATHETER WITH PURCHASE IN THE HIGH CERVICAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). A COMPETITOR GUIDE WIRE WAS ADVANCED UNTIL IT CROSSED THE CLOT IN M3 MCA, AND THE ZOOM 35 WAS ADVANCED TO THE FACE OF THE CLOT. THE M3 MCA VESSEL SIZE WAS NOTED TO BE APPROXIMATELY 1.5MM. ONE PASS WAS PERFORMED, AND UPON REMOVAL OF THE ZOOM 35 CLOT APPEARED TO BE ON THE DISTAL TIP. ANGIOGRAM PERFORMED AFTER THE FIRST PASS INDICATED A VESSEL PERFORATION IN THE M3 MCA. THE OPERATOR BELIEVES THE PERFORATION WAS DUE TO PATIENT MOVEMENT DURING THE ASPIRATION PROCEDURE. THE CASE WAS CONCLUDED AND THE PATIENT WAS INTUBATED TO MANAGE THE BLEEDING. THE STROKE SELF-RESOLVED AND PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Perforation of Vessels

  MAUDE report 12136379 ↗
• InjuryJul 2, 2021Break; Break

  PATIENT PRESENTED WITH SAGITTAL SINUS THROMBOSIS. ACCESS WAS OBTAINED WITH A ZOOM 88 ADVANCED OVER A COMPETITOR SUPPORT CATHETER AND 0.035 GUIDEWIRE IN THE TRANSVERSE SINUS. ZOOM 55 WAS SUBSEQUENTLY ADVANCED TO THE CLOT AND HOOKED UP TO THE ASPIRATION PUMP FOR MECHANICAL THROMBECTOMY. ONCE UNDER ASPIRATION, THE PHYSICIAN RAPIDLY ADVANCED AND RETRACTED THE ZOOM 55 WITHIN THE SAGITTAL SINUS FOR APPROXIMATELY 15 SECONDS. DURING THE ZOOM 55 REMOVAL IT WAS OBSERVED THAT THE MID SHAFT SEPARATED, WITH APPROXIMATELY 20CM OF DISTAL SHAFT REMAINING IN THE PATIENT. THE PHYSICIAN PROCEEDED TO REMOVE THE SEPARATED DISTAL SHAFT BY INFLATING A BALLOON CATHETER AND ANCHORING THE SEPARATED ZOOM 55 SEGMENT, AND SUBSEQUENTLY RETRACTING IT INTO THE GUIDE CATHETER. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NEW ZOOM 71. PATIENT IS CURRENTLY STABLE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112503 ↗
• InjuryMay 26, 2021Break; Break

  THE PATIENT WAS UNDERGOING A STROKE CASE WITH BASILAR OCCLUSION. ACCESS WAS OBTAINED WITH A COMPETITOR ACCESS CATHETER UTILIZING A RADIAL APPROACH. THE ZOOM 71 WAS ADVANCED TO THE TARGET CLOT LOCATION WITH A COMPETITOR MICROCATHETER AND 0.014" GUIDEWIRE, BUT WAS WEDGED INTO THE DISEASED PLAQUE IN THE VERTEBRAL ARTERY. WHILE ATTEMPTING TO PULL OUT THE ZOOM 71 THE OPERATOR ENCOUNTERED RESISTANCE, AND UPON FURTHER RETRACTION THE ZOOM 71 RELEASED. INSPECTION OF THE REMOVED ZOOM 71 RESULTED IN THE TIP BEING OBSERVED AS SEPARATED. THE OPERATOR ATTEMPTED TO RETRIEVE THE SEPARATED TIP WITH A COMPETITOR STENT RETRIEVER AND WAS UNSUCCESSFUL. THE OPERATOR THEN ATTEMPTED TO ADVANCE A COMPETITOR INTERMEDIATE CATHETER WITH A NEW ACCESS CATHETER AND MICROCATHETER, BUT WAS ALSO UNABLE TO NAVIGATE TO THE SITE OF THE OCCLUSION. THE CASE WAS CONCLUDED AFTER USE OF THE COMPETITOR INTERMEDIATE CATHETER. THE PATIENT STATUS IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886573 ↗
• MalfunctionMay 11, 2021Break; Break

  INITIAL EVENT DESCRIPTION: PATIENT HAD A LEFT MCA ARTERY OCCLUSION. ACCESS WAS OBTAINED WITH A TRACSTAR IN THE CAVERNOUS ICA IN A GOOD DISTAL POSITION. THE PHYSICIAN MADE 1 PASS WITH ZOOM 71 TO THE CLOT AND ASPIRATED, NO CLOT WAS RETRIEVED. NO RESISTANCE WAS FELT WHILE ADVANCING THE ZOOM 71 TO THE CLOT LOCATION. PHYSICIAN MAY HAVE TRIED TO PUSH THE TRACSTAR INTO THE MCA WITHOUT SUCCESS THAT MAY HAVE BEEN CAUSE OF THE KINK IN TRACSTAR. PULLED BACK Z71 AT THIS POINT AND FELT RESISTANCE WHILE WITHDRAWING. UPON REMOVAL, NOTICED A KINK IN TRACSTAR AND THE Z71 TIP WAS DEFORMED. PHYSICIAN REPORTED THAT THE TIP OF THE ZOOM 71 WAS DEFORMED AND REMOVED THE TRACSTAR. IT WAS NOTED THAT NO PART OF THE CATHETER WAS LEFT BEHIND IN THE PATIENT AND THERE WAS NO HARM CAUSED TO THE PATIENT FROM THIS. HE COMPLETED THE PROCEDURE WITH A NEURON MAX .088 SHEATH AND A SOFIA .070 CATHETER. ACHIEVED TICI 3 REPERFUSION AFTER 1 PASS WITH SOFIA CATHETER. THERE WERE NO CLINICAL EVENT REPORTED. BASED ON POST OP CT THE PHYSICIAN MENTIONED THAT THE PATIENT LIKELY STILL HAD SOME RESIDUAL STROKE OF THE LEFT TERRITORY. THE INITIAL REPORTABILITY FOR THIS COMPLAINT WAS DETERMINED TO BE NOT REPORTABLE BASED ON THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810042 ↗

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