SAFARI2Recalls & reported problems across all models

We found 7 models of SAFARI2 by Lake Region Medical in the FDA's device registry (GUDID). Together they are named in 207 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2019 and Aug 11, 2026 — classified as 27 deaths, 21 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (100 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 SAFARI2 problems

SAFARI2 models

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

• SAFARI2™ H74939406XS0

  Wire, Guide, Catheter
  7 deaths53 reports
• SAFARI2™ H74939407XS0

  Wire, Guide, Catheter
  9 deaths50 reports
• SAFARI2™ H74939407S0

  Wire, Guide, Catheter
  4 deaths40 reports
• SAFARI2™ H74939406S0

  Wire, Guide, Catheter
  3 deaths30 reports
• SAFARI2™ H74939706JPNXS0

  Wire, Guide, Catheter
  3 deaths26 reports
• SAFARI2™ H74939706JPNS0

  Wire, Guide, Catheter
  1 death7 reports
• Safari2 H74939661S1

  Wire, Guide, Catheter
  1 report

Recent SAFARI2 adverse event reports

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

• MalfunctionAug 11, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216090 ↗
• MalfunctionAug 11, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216089 ↗
• DeathJun 26, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH SEVERE AORTIC VALVE STENOSIS UNDERWENT A TAVI PROCEDURE. DURING ADVANCEMENT OF THE NAVITOR TRANSCATHETER HEART VALVE SYSTEM WITH FLEXNAV DELIVERY SYSTEM ACROSS THE AORTIC VALVE, ST-SEGMENT ELEVATION, HYPOTENSION, AND CIRCUMFERENTIAL PERICARDIAL EFFUSION WERE OBSERVED. PERICARDIOCENTESIS WAS PERFORMED, AND BLOODY PERICARDIAL DRAINAGE WAS CONFIRMED. ECMO WAS SUBSEQUENTLY INITIATED. THE PHYSICIAN DIAGNOSED CARDIAC TAMPONADE. AN EMERGENCY THORACOTOMY WAS PERFORMED AND REVEALED A LEFT VENTRICULAR APEX PERFORATION. LEFT VENTRICULAR REPAIR WAS PERFORMED, AND HEMOSTASIS WAS ACHIEVED. THE PROCEDURE WAS COMPLETED WITHOUT VALVE IMPLANTATION. THE PATIENT DIED THE SAME DAY, WITH THE CAUSE OF DEATH REPORTED AS LEFT VENTRICULAR PERFORATION. THE PHYSICIAN'S OPINION WAS THAT THE PERFORATION WAS CAUSED BY THE SAFARI2 GUIDEWIRE USED DURING THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THE GUIDEWIRE FUNCTIONED NORMALLY WITH NO REPORTED MALFUNCTIONS. THE PROCEDURE WAS COMPLICATED BY SEVERE AORTIC TORTUOSITY AND SIGNIFICANT CALCIFICATION OF THE AORTIC VALVE LEAFLETS, WHICH MADE ADVANCEMENT OF THE TAVI DELIVERY SYSTEM MORE DIFFICULT THAN USUAL. A LONG SHEATH WAS USED TO ADDRESS THE

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 25635584 ↗
• DeathJun 19, 2026Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: THE PATIENT UNDERWENT A TAVI PROCEDURE VIA THE LEFT SUBCLAVIAN ARTERY DUE TO SEVERE AORTIC VALVE STENOSIS. DURING THE PROCEDURE, THE ARTERY WAS PUNCTURED, AND IN THE USUAL MANNER, AN INTRODUCER SHEATH (MEDTRONIC) AS WELL AS A GUIDEWIRE (BOSTON SCIENTIFIC SAFARI XS WIRE) WERE ADVANCED THROUGH THE ARTERY, ACROSS THE NATIVE STENOTIC VALVE, AND INTO THE LEFT VENTRICLE OF THE HEART. THE TAVI VALVE (MEDTRONIC EVOLUT FX+) WAS BEING DEPLOYED NORMALLY WHEN THE PATIENT'S BLOOD PRESSURE SUDDENLY COLLAPSED, AND RESUSCITATION WAS IMMEDIATELY INITIATED. THE PARTIALLY DEPLOYED TAVI VALVE WAS WITHDRAWN BACK INTO THE DELIVERY CATHETER. BLEEDING INTO THE PERICARDIAL SPACE WAS IDENTIFIED, AND PERICARDIOCENTESIS WAS PERFORMED WHILE RESUSCITATION WAS ONGOING. THE BLEEDING CONTINUED, THE SITUATION DID NOT STABILIZE DURING 25 MINUTES OF RESUSCITATION, AND THE PATIENT WAS PRONOUNCED DECEASED. THE CLINICAL SUSPICION AT THE TIME OF THE EVENT WAS THAT THE OUTCOME MAY HAVE BEEN ASSOCIATED WITH EITHER A PERFORATION OF THE LEFT VENTRICLE OR INJURY TO THE AORTIC ROOT. IN THE FORENSIC DETERMINATION OF THE CAUSE OF DEATH, PERFORATION OF THE LEFT VENTRICLE WAS IDENTIFIED. A DEFINITIVE CAUSE OF T

  Patient problems: Cardiac Perforation

  MAUDE report 25562984 ↗
• DeathApr 6, 2026Adverse Event Without Identified Device or Use Problem

  PER MEDSUN REPORT (B)(4): THE RIGHT FEMORAL ARTERY SHEATH WAS EXCHANGED FOR A 18 FRENCH SHEATH. THROUGH THIS SHEATH, THE AORTIC VALVE WAS CROSSED AND SIMULTANEOUS PRESSURES WERE OBTAINED FROM THE LEFT VENTRICLE AND THE AORTIC ROOT. DURING THE DEPLOYMENT OF THE STIFF WIRE IN THE LEFT VENTRICLE IT WAS NOTED WITH THE PATIENT'S BLOOD PRESSURE DROPPED SUDDENLY AND LEFT VENTRICULAR RUPTURE WITH PERICARDIAL TAMPONADE WAS DIAGNOSED. IT IS CURRENTLY UNKNOWN IF THIS WAS AN ISSUE WITH THE PRODUCT OR A USER ERROR. IT IS CURRENTLY BELIEVED THAT THE WIRE WAS DEFECTIVE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: TAVR TRANSCATHETER AORTIC VALVE REPLACEMENT].

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 24790744 ↗
• MalfunctionMar 9, 2026Material Split, Cut or Torn

  THE TIP OF THE GUIDEWIRE WAS FRACTURED WHEN THE PACKAGE WAS OPENED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. WAS THE PROBLEM ASSOCIATED WITH LABELED USE? YES. EVENT RESOLVED? YES. ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: NONE. PATIENT OUTCOME FROM THE EVENT: NONE. ADDITIONAL INFORMATION PROVIDED 03 MAR 2026: QUESTION: PHOTO OF THE TIP OF THE WIRE INCLUDING A CLOSE-UP WHERE THE DAMAGE OCCURRED? ANSWER: UNKNOWN PER CUSTOMER. QUESTION: IS THE WIRE DAMAGE A TRUE FRACTURE (TWO OR MORE SEPARATE PIECES)? OR IS THERE COIL ONLY DAMAGE (OUTER COIL MATERIAL DISRUPTED SUCH AS STRETCHING, MISALIGNMENT, OFFSET)? ANSWER: UNKNOWN PER CUSTOMER. QUESTION: IF THE DAMAGE IS A TRUE FRACTURE, IS THE CORE OR COIL MATERIAL IN TWO PIECES OR BOTH? ANSWER: UNKNOWN PER CUSTOMER. QUESTION: WAS THERE ANY DAMAGE NOTED TO THE PACKAGING? ANSWER: NO. QUESTION: WHAT IS MEANT BY PACKAGING (I.E., 1 PACK CARTON, POUCH)? ANSWER: THE PACK CARTON AND POUCH WERE NOT DAMAGED. QUESTION: HO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547940 ↗
• MalfunctionMar 9, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: OUTER LAYER OF SAFARI WIRE WAS BROKEN AND SPLIT, DETECTED BY NURSE UPON DEVICE PREPARATION. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: FULLY RECOVERED. WAS ISSUE PRESENT UPON OPENING PACKAGE? YES. IF THE PACKAGING WAS DAMAGED, DESCRIBE: NO DAMAGE TO PACKAGING. IF YES, WAS THE PACKAGING DAMAGED? YES. ADDITIONAL INFORMATION RECEIVED 02 MAR 2026: QUESTION: IT WAS REPORTED THAT THE OUTER LAYER WAS BROKEN AND SPLIT, CAN YOU DESCRIBE THE DAMAGE AND WHAT THE "OUTER LAYER" IS REFERRING TO? WERE THE COILS SEPARATED/UNRAVELED? ANSWER: YES. QUESTION: WAS THIS AN ISSUE WITH THE COATING? ANSWER: NO. QUESTION: WAS THIS A DEVICE FRACTURE (WHERE THE DEVICE WAS BROKEN, BUT NOT COMPLETELY SEPARATED)? ANSWER: NOT BROKEN COMPLETELY. IF THE DEVICE IS FRACTURED, DID THE SEPARATION INVOLVE THE CORE WIRE, THE OUTER COIL WIRE, OR BOTH? ANSWER: OUTER COIL LOOKS SEPARATED AT DISTAL END OF WIRE (AWAY FROM COIL). QUESTION: WAS THERE A COMPLETE SEPARATION (DEVICE BROKEN INTO TWO SEPARATE PARTS)? ANSWER: NO. QUESTION: WHERE ON THE DEVICE WAS THIS DAMAGE? ANSWER: MAINLY ON THE COIL. QUESTION: CAN YOU PLEASE CLARIFY, WAS THERE DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545123 ↗
• MalfunctionFeb 25, 2026Entrapment of Device

  THE NAVIGATOR CATHETER WITH THE MOUNTED HEART VALVE CANNOT BE MOVED FORWARDS OR BACKWARDS ON THE GUIDEWIRE BEFORE PLACEMENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? PUSHED AND PULLED. WHAT IS THE NEXT COURSE OF ACTION?: RETRACTED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: EXPECTED TO FULLY RECOVER. ADDITIONAL INFORMATION: QUESTION: WAS THE PHYSICIAN ULTIMATELY ABLE TO RETRACT THE SAFARI2 NORMALLY, OR DID THE SAFARI2 AND VALVE SYSTEM NEED TO BE REMOVED TOGETHER AS A UNIT? ANSWER: TOGETHER AS ONE UNIT. QUESTION: DO YOU KNOW HOW FAR INTO THE ANATOMY THE VALVE SYSTEM WAS WHEN THE ISSUE OCCURRED (E.G. AT THE LEVEL OF THE AORTIC VALVE)? ANSWER: YES, AT THE HEIGHT THEY WANTED TO IMPLANT. QUESTION: WAS ANY DAMAGE OBSERVED TO THE SAFARI2 PRIOR TO THE PROCEDURE OR AFTER REMOVAL FROM THE ANATOMY? ANSWER: NOT PRIOR THE PROCEDURE, AFTERWARDS THE COMPETETOR TOOK EVERYTHING. QUESTION: PLEASE CONFIRM THE DISPOSITION OF THE SAFARI2 WIRE. WAS IT DISPOSED, OR IS IT AVAILABLE FOR RETURN? ANSWER: THE DEVICE WAS DISCARDED AT THE FACILITY AND WILL NOT BE RETURNING. QUESTION: HOW WAS THE TAVR COMPLETED? WITH A NEW SAFARI2, DIFFERENT BRAND WIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445763 ↗
• MalfunctionFeb 23, 2026Material Split, Cut or Torn

  THE PATIENT'S BLOOD VESSEL WAS TORTUOUS AND CALCIFIED, THE GUIDEWIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE?: STABLE WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT WAS THE PROBLEM ASSOCIATED WITH LABELED USE?: YES. EVENT RESOLVED?: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413858 ↗
• MalfunctionFeb 5, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: IT WAS REPORTED BY EMAIL THAT 'UNABLE TO PACE THROUGH WIRE AND INTERMITTENT FAILURE TO CAPTURE. ? BREAK WITHIN WIRE. CHANGED PACING BOX AND DID NOT RESOLVE ISSUE. THE TEAM DID NOT RETAIN THE WIRE. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: EXPECTED TO FULLY RECOVER. ADDITIONAL INFORMATION PROVIDED ON 23JAN2026: CLARIFICATION ON "BREAK WITHIN WIRE" QUESTION: DOES THIS REFER TO A COMPLETE FRACTURE (WIRE IN 2 PIECES), OR AN OFFSET, KINK, BEND, OR STRETCHED MATERIAL? PLEASE PROVIDE A DETAILED DESCRIPTION OF THE OBSERVED CONDITION. ANSWER: WE'RE ASSUME ITS A NON VISIBLE BREAK I.E. INSIDE THE WIRE MATERIAL AS IT CAUSED LOSS OF PACING AND INTERMITTING OVERSENSING/INAPPROPRIATE PACING. SIMILAR TO WHAT YOU WOULD SEE IN A FRACTURED ICD LEAD. QUESTION: WHAT DOES THE PHYSICIAN BELIEVE CAUSED THE BREAK? ANSWER: NO CAUSE FOUND, LIKELIHOOD IS PRODUCT WAS FAULTY AT START. QUESTION: WAS ANY DAMAGE TO THE GUIDEWIRE VISUALLY OBSERVED PRIOR TO INSERTION/UPON OPENING THE DEVICE? ANSWER: NO. QUESTION: WERE THERE ANY PATIENT COMPLICATIONS RELATED TO THE CAPTURE FAILURE? ANSWER: NO. QUESTION: HOW WAS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269840 ↗
• MalfunctionFeb 4, 2026Entrapment of Device

  THE PROBLEM WAS THAT THE WIRE WAS DAMAGED DURING INSERTION INTO THE PATIENT. AFTER TRANSSEPTAL PUNCTURE WAS PERFORMED, THE WIRE WAS ADVANCED INTO THE LEFT ATRIUM THROUGH THE SL0 SHEATH. THE WIRE BECAME STUCK INSIDE THE SL0 AND COULD NOT BE ADVANCED OR WITHDRAWN. THE WIRE WAS FOUND TO BE DAMAGED AFTER IT WAS REMOVED. QUESTION: IT IS NOTED THAT THE SAFARI2 WIRE WAS USED IN A PFA + LAAC PROCEDURE. CAN YOU CONFIRM THIS IS CORRECT? ANSWER: YES, USED FOR PFA+LAAC PROCEDURE FOR TRANSEPTAL SHEATH EXCHANGE. QUESTION: DID THE SAFARI2 WIRE AND SL0 SHEATH NEED TO BE REMOVED TOGETHER AS A UNIT (OR WAS THE WIRE ULTIMATELY ABLE TO BE WITHDRAWN NORMALLY FROM THE SHEATH)? ANSWER: YES, SAFARI AND SL0 ARE REMOVED TOGETHER. QUESTION: HOW FAR INTO THE PATIENT ANATOMY WAS THE SAFARI2 ADVANCED WHEN THE ISSUE OCCURRED (E.G. ALL THE WAY TO THE LA)? ANSWER: NOT FAR, BECAUSE STUCK ON TIP OF SL0. QUESTION: WAS ANY DAMAGE OBSERVED TO THE SAFARI2 WIRE PRIOR TO INSERTION? ANSWER: NO. QUESTION: CAN YOU DESCRIBE THE DAMAGE OBSERVED: LOCATION ON THE WIRE (TIP, DISTAL END, MID PORTION, ETC.)? ANSWER: DISTAL END OF SAFARI. QUESTION: TYPE OF DAMAGE (KINK, COATING ISSUE, ETC.)? ANSWER: AFTER REMOVED FROM PATIENT BODY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260788 ↗
• MalfunctionJan 29, 2026Flaked

  NOTE: THIS REPORT ADDRESSES THE SECOND OF TWO INCIDENTS REFERENCED IN THE EVENT DESCRIPTION. THE FIRST INCIDENT IS CAPTURED SEPARATELY IN MDR 2126666-2026-00003. EVENT DESCRIPTION: WHEN THEY USED IT, THE COATING FLARES OFF DURING USE. FURTHER INFORMATION REPORTED THEY USED TWO; AND BOTH HAD THE SAME ISSUE. ADDITIONAL INFORMATION: QUESTION: WERE ALL WIRES USED IN THE SAME CASE/SAME PATIENT? ANSWER: NO. QUESTION: PATIENT PRESENT AT TIME OF EVENT: ANSWER: YES. QUESTION: PATIENT COMPLICATIONS: ANSWER: NO PATIENT COMPLICATIONS. QUESTION: PATIENT OUTCOME: ANSWER: FULLY RECOVERED. QUESTION: PROCEDURE DATE: ANSWER: UNAVAILABLE PER ACCT/CUSTOMER. QUESTION: WAS ISSUE PRESENT UPON OPENING PACKAGE? ANSWER: NO. QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: NO. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC.) ANSWER: N/A. QUESTION: WHEN SPECIFICALLY, DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: WHEN YOU ARE LOADING DEVICE ON THE SAFARI THE COATING FLARES OFF (EX BALLOON, DELIVERY SYSTEM). QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER: ON THE END OF THE SAFARI WIRE (THE STRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210284 ↗
• MalfunctionJan 29, 2026Flaked

  NOTE: THIS REPORT ADDRESSES THE FIRST OF TWO INCIDENTS REFERENCED IN THE EVENT DESCRIPTION. THE SECOND INCIDENT IS CAPTURED SEPARATELY IN MDR 2126666-2026-00004. EVENT DESCRIPTION: WHEN THEY USED IT, THE COATING FLARES OFF DURING USE. FURTHER INFORMATION REPORTED THEY USED TWO; AND BOTH HAD THE SAME ISSUE. ADDITIONAL INFORMATION: QUESTION: WERE ALL WIRES USED IN THE SAME CASE/SAME PATIENT? ANSWER: NO. QUESTION: PATIENT PRESENT AT TIME OF EVENT: ANSWER: YES. QUESTION: PATIENT COMPLICATIONS: ANSWER: NO PATIENT COMPLICATIONS QUESTION: PATIENT OUTCOME: ANSWER: FULLY RECOVERED QUESTION: PROCEDURE DATE ANSWER: UNAVAILABLE PER ACCT/CUSTOMER QUESTION: WAS ISSUE PRESENT UPON OPENING PACKAGE? ANSWER: NO QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: NO QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC.)? ANSWER: N/A. QUESTION: WHEN SPECIFICALLY, DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: WHEN YOU ARE LOADING DEVICE ON THE SAFARI THE COATING FLARES OFF (EX BALLOON, DELIVERY SYSTEM). QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER: ON THE END OF THE SAFARI WIRE (THE STRAIGHT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210276 ↗
• InjuryJan 13, 2026Insufficient Device Problem Information

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE SAFARI WIRE IN ADVANCING PROCESS CAUSED DISSECTION WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: YES. WHAT IS THE NEXT COURSE OF ACTION?: UNKNOWN. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: DISSECTION IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? UNKNOWN MEDICAL OR SURGICAL INTERVENTIONS: USED ANOTHER DEVICE PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN PATIENT OUTCOME: UNKNOWN WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. PATIENT COMPLICATIONS QUESTIONS: QUESTION: DESCRIBE ANY PATIENT SYMPTOMS THAT OCCURRED RELATED TO THE DISSECTION: ANSWER: DETAILS NOT PROVIDED BY HOSPITAL QUESTION: WAS ANY INTERVENTION REQUIRED TO TREAT THE DISSECTION? ANSWER: DETAILS NOT AVAILABLE QUESTION: WAS THE DISSECTION FLOW LIMITING? ANSWER: UNKNOWN QUESTION: WHAT ACTIONS WERE TAKEN AS A RESULT OF THE ISSUE? ANSWER: UNKNOWN QUESTION: WHAT BSC DEVICES WERE USED PRIOR TO DISSECTION? ANSWER: UNKNOWN QUESTION: WHAT IS THE ANATOMICAL LOCATION OF THE LESION B

  Patient problems: Insufficient Information

  MAUDE report 24057069 ↗
• MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE ISSUE BECAME WHEN TRYING TO RETRACT THE WIRE THROUGH THE EDWARDS VALVE DELIVERY SYSTEM. THE WIRE BECAME HARD TO RETRACT AND THE TIP UNRAVELED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? HAD TO PUT VERY HARD TO GET THE WIRE TO COME OUT. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: FULLY RECOVERED. PROCEDURE DATE: UNKNOWN. WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. PROCEDURE OUTCOME: ORIGINAL METHOD/DEVICE USED. QUESTION: ANY RESISTANCE ENCOUNTERED DURING ADVANCEMENT THROUGH ANATOMY? ANSWER: NO. QUESTION: HOW WAS THE PROCEDURE COMPLETED - WERE ANY DEVICES EXCHANGED (IF YES, PLEASE SPECIFY)? ANSWER: NO. QUESTION: WHERE IN THE PATIENT ANATOMY WAS THE DIFFICULTY ENCOUNTERED? ANSWER: UNKNOWN. QUESTION: WAS THERE A DEVICE INTERACTION WITH ANOTHER DEVICE? IF YES, PLEASE EXPLAIN AND PROVIDE OTHER PRODUCT DETAILS: ANSWER: EDWARDS DELIVERY SYSTEM. QUESTION: WAS ANY DEVICE DAMAGE NOTED? IF YES, PLEASE SPECIFY WHERE. ANSWER: TIP OF WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830460 ↗

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