SAFARI2™ H74939406XS0Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729887621), received between Jul 1, 2019 and Aug 11, 2026 — classified as 7 deaths, 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, 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 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 THE PARTIALLY DEPLOYED TAVI VALVE WAS WITHDRAWN BACK INTO THE DELIVERY CATHETER.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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: SAFARI UNRAVELED IN THE BODY BUT WAS REMOVED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH A NEW SAFARI WITH NO HARM TO THE PATIENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN WHAT IS THE NEXT COURSE OF ACTION?: REPLACE PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500584 ↗
• MalfunctionJan 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: ON REMOVING THE SAFARI WIRE AT THE COMPLETION OF THE PROCEDURE IT WAS NOTICED THAT THE COIL OF THE WIRE HAD DELAMINATED FROM THE CORE WIRE. NO COMPLICATIONS FOR THE PATIENT AND CASE COMPLETED SUCCESSFULLY. THE DOCTOR QUOTED THAT THEY HAD BEEN PUTTING A LOT OF SHEARING FORCE BACK AND FORTH ALONG THE WIRE WHEN TRYING TO DEPLOY THE MEDTRONIC VALVE MULTIPLE TIMES. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NA . WHAT IS THE NEXT COURSE OF ACTION?: NONE NEEDED- THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: NO. QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: UNKNOWN BUT HINTING TOWARDS THE FORCE OF THE DEVICE TIP ON THE WIRE QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: UNKNOWN. QUESTION: WHEN SPECIFICALLY DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: AT THE END OF THE PROCEDURE WHEN REMOVING THE WIRE FROM THE CATHETER QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113170 ↗
• MalfunctionSep 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE WIRE COULD NOT BE ADVANCED OUT OF THE PLASTIC PROTECTIVE HOUSING, NOR COULD IT BE PULLED BACK. WHEN FORCEFULLY PULLED BACK, IT UNRAVELED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NONE, NEW WIRE TAKEN PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. QUESTION: HOW WAS THE PROCEDURE COMPLETED - WERE ANY DEVICES EXCHANGED (IF YES, PLEASE SPECIFY)? ANSWER: TOOK A NEW WIRE, NO. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: NONE. QUESTION: WAS ANY DEVICE DAMAGE NOTED? IF YES, PLEASE SPECIFY WHERE. ANSWER: YES, DEVICE DAMAGED TRYING TO REMOVE FROM PACKAGING QUESTION: WHAT WAS THE SUSPECTED CAUSE OF THE REPORTED EVENT? ANSWER: NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182597 ↗
• MalfunctionMay 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: WHEN PULLING THE WIRE OUT, IT WAS ONLY POSSIBLE TO PULL IT OUT WITH A LOT OF FORCE. THIS DAMAGED THE TIP. A NEW SAFARI WIRE WAS USED. PATIENT PRESENT AT TIME OF EVENT?: NO . PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS WAS ISSUE PRESENT UPON OPENING PACKAGE?: YES. IF YES, WAS THE PACKAGING DAMAGED?: NO. PHOTO OR VIDEO OF ISSUE: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370881 ↗
• MalfunctionMar 19, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: AFTER RELEASE FROM A NAVITOR IT WAS NOT POSSIBLE TO SWITCH THE SAFARI IN ANY DIRECTION. THE SAFARI WIRE HAD TO BE PULLED WITH THE COMPLETE DELIVERY CATHETER OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: THEY PULLED THE WHOLE SYSTEM INCLUDING THE WIRE OUT OF THE PATIENT. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. QUESTION: ARE ANY PATIENT STATUS UPDATES AVAILABLE? ANSWER: PATIENT OUTCOME GOOD. ADDITIONAL INFORMATION RECEIVED 15MAR2024: QUESTION: WHAT DOES IT MEAN, "IT WAS NOT POSSIBLE TO SWITCH THE SAFARI IN ANY DIRECTION"? ANSWER: THE GUIDEWIRE STUCK INSIDE THE DELIVERY CATHETER, WAS NOT POSSIBLE TO PULL IT OUT, NEITHER OUTSIDE OF THE PATIENT. QUESTION: WHAT WAS THE REASON FOR THE SAFARI GUIDEWIRE HAVING TO BE PULLED WITH THE COMPLETE DELIVERY CATHETER OUT OF THE PATIENT? ANSWER: THE GUIDEWIRE STUCK INSIDE THE DELIVERY CATHETER, WAS NOT POSSIBLE TO PULL IT OUT, NEITHER OUTSIDE OF THE PATIENT. QUESTION: IS THE GUIDEWIRE STUCK INSIDE THE DELIVERY CATHETER? ANSWER: THE GUIDEWIRE STUCK INSIDE THE DELIVERY CATHETER, WAS NOT POSSIBLE TO PULL IT OUT, NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932502 ↗
• MalfunctionMar 11, 2024Malposition of Device; Malposition of Device

  EVENT DESCRIPTION: WE DIDN'T KNOW WE WERE GOING TO TREAT A VALVE IN VALVE( HANCOK 25) PATIENT JUST UNTIL WE REACHED THE HOSPITAL AS THIS AS AN URGENT REQUEST FROM THE HOSPITAL. THE ORDER WAS PLACED IN THE MORNING AND IN THE AFTERNOON, WE WERE AT THE HOSPITAL. WHILE CRIMPING THE VALVE PHYSICIANS PERFORMED THE BALLOON AORTIC VALVULOPLASTY (BAV) AND PLACEMENT OF PIGTAIL WIRE ( THIS PHYSICIANS ARE ONE OF THE BEST IN THE COUNTRY AND THEY ARE DOING THE PROCEDURE REALLY FAST) AFTER INSERTING THE DELIVERY SYSTEM, I SAW THAT THE SAFARI WIRE WAS LOOKING A LITTLE FUNNY AND I ASKED THEM 2 TIMES TO CHECK AND REPOSITION THE LOOP BUT THEY WERE KEEN ON DEPLOYING THE VALVE POSITION SEEMED GOOD BUT ON KNOB 2 RELEASE THE STENT HOLDER DIDN'T DISENGAGE FROM THE HOOKS. WE TRIED TO MANAGE THE SAFARI AND CLOSE KNOB 1, DO A LITTLE PUSH ON THE DELIVERY SYSTEM BUT THIS TIME IT SEEMED LIKE THE MEMBRANE WAS STUCK ON THE LOWER CROWN. THEY SWITCHED THE SAFARI WITH A STRAIGHT TIP WIRE AND DECIDED TO EMBOLIZE AND SNARE THE VALVE IN THE AORTA TO PREPARE FOR SECOND VALVE AS IT WAS TOO DIFFICULT TO MANAGE TO DETACH THE MEMBRANE WHILE AT ANNULUS LEVEL. IN THE PROCESS THEY LOST ACCESS TO THE VENTRICLE WHILE THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876263 ↗
• MalfunctionFeb 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DESCRIBE THE EVENT OR PROBLEM: INITIAL EVENT SEVERITY RATING: EVENT DID NOT REACH PATIENT OR DID NOT CAUSE HARM. EVENT DESCRIPTION: TIP OF THE WIRE UNRAVELED BEFORE GOING INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647021 ↗
• MalfunctionAug 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: WHEN INSERTING THE SAFARI2 XS WIRE, THERE WAS DAMAGE TO THE END OF THE WIRE. A NEW WIRE WAS USED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: USE A NEW SAFARIXS WIRE PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS QUESTION: ARE ANY PATIENT STATUS UPDATES AVAILABLE? ANSWER: NO PATIENT HARM. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES ETC)? ANSWER: DAMAGE DURING UNPACKING. QUESTION: WHEN SPECIFICALLY DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: START OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565811 ↗
• MalfunctionAug 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: SAFARI WIRE OPENED TO USE FOR TAVI PROCEDURE WITH INTENTION TO INSERT INTO CATHETER THAT WAS SITTING IN THE LV AND THEN REMOVE THE CATHETER SO THAT THE VALVE COULD BE INTRODUCED. AS SHOWN IN THE PICTURE, THERE APPEARS TO BE A SHEARING OF THE COATING ON THE SAFARI WIRE AND THEREFORE IT COULD NOT BE INTRODUCED INTO THE CATHETER IN SITU. A NEW SAFARI WIRE WAS TAKEN FROM THE SAME BOX AND THAT WORKED AS INTENDED WITH NO DEFECT, THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457765 ↗
• MalfunctionJul 26, 2023Malposition of Device; Malposition of Device

  EVENT DESCRIPTION: ASCENDING AORTIC DISSECTION (001- MAJOR VASCULAR COMPLICATION)/ COAGULOPATHY (002- BLEEDING EVENT (MAJOR OR LIFE THREATENING)/ COAGULOPATHY (0021-DEATH)/ HYPOXIC RESPIRATORY FAILURE (003- SAE)/ DISLOCATION OF SAFARI WIRE (OTHER PRODUCT ISSUE): ON (B)(6) 2023, DURING INDEX PROCEDURE, AS THE DELIVERY SYSTEM WAS INTRODUCED INTO THE SHEATH AND BEING ADVANCED, IT WAS NOTED THAT THE SAFARI WIRE HAD DISLODGED FROM THE VENTRICLE (OTHER PRODUCT ISSUE) AND WAS IN THE SUPRA-ANNULAR POSITION WITHIN THE ASCENDING AORTA. IMMEDIATELY THIS WAS WATCHED UNDER FLUOROSCOPY AND THE VALVE DELIVERY SYSTEM WAS EASILY REMOVED. THE VALVE WAS TAKEN BACK TO THE TABLE AND FLUSHED. IT APPEARED TO BE UNCOMPROMISED, SO IT WAS NOT RELOADED (NOT ASSOCIATED WITH DEVICE DEFICIENCY). THE VALVE DELIVERY SYSTEM WAS REINTRODUCED INTO THE SHEATH. THE VALVE WAS ADVANCED AROUND THE AORTIC ARCH AND SLOWLY WAS BEGAN CROSSING ANNULUS. AFTER REACHING THE CORRECT POSITION, THE FIRST KNOB WAS SLOWLY TURNED, AND UPPER CROWN OF THE VALVE WAS DEPLOYED. THE POSITION OF THE VALVE WAS CHECKED IN MULTIPLE GANTRY ANGLE, THE POSITION OF THE VALVE APPEARED TO BE TOO HIGH AND NOT DEEP ENOUGH (NOT REPORTABLE). GENTLE FORWA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397382 ↗
• MalfunctionJul 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: GUIDE WIRE WAS REPORTED TO THE COORDINATOR AS HAVING UNRAVELED. THE WIRE WAS REMOVED AND REPLACED WITH A LUNDERQUIST WIRE TO USE FOR THE PROCEDURE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: THE DEVICE WAS REMOVED. WHAT IS THE NEXT COURSE OF ACTION?: REMOVED FOR LUNDERQUIST. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392099 ↗
• MalfunctionJun 28, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT: UNABLE TO REMOVE THE GUIDE CATHETER FROM THE VALVE. ONCE SUCCESSFUL, THE GUIDE BROKE. CLINICAL CONSEQUENCES AND CURRENT PATIENT STATUS: NONE ACTIONS TAKEN FOR THE PATIENT IN REGARDS TO THE DEVICE: REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216696 ↗
• OtherJun 21, 2023Mechanical Jam

  ELDERLY MALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE) AND SEVERE AORTIC STENOSIS. PROCEDURE: TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT). DURING THE PROCEDURE, THE SAFARI WIRE GOT STUCK IN THE DELIVERY SYSTEM. THE ENTIRE SYSTEM WAS REMOVED WITH WIRE, INTACT- INSIDE. A NEW SYSTEM AND WIRE WAS USED SUCCESSFULLY WITHOUT ISSUES. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED, SAPIEN 3 ULTRA SYSTEM (PER SITE REPORTER). WILL OBTAIN. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, SAFARI2 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170970 ↗
• MalfunctionMay 12, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: SAFARI WAS NOT USED BECAUSE ALREADY WHILE THE PHYSICIAN TOOK THE WIRE OUT OF THE SNAIL, HE NOTICED THAT THE WIRE WAS NOT COVERED AND THERE WAS AN 'EDGE.' WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: N.A: WHAT IS THE NEXT COURSE OF ACTION?: N.A: PATIENT PRESENT AT TIME OF EVENT?: NO PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS NOTE: THIS MEDWATCH REPORT IS BEING FILED BASED ON THE IMAGES RECEIVED ALONG WITH THE PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918940 ↗
• MalfunctionApr 10, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: THE PHYSICIANS PACED OFF THE SAFARI WIRE. AFTER THE S3 TAVR DEVICE WAS DEPLOYED THEY ATTEMPTED TO PULL BACK THE SAFARI WIRE BUT IT WAS STUCK. THE WIRE WOULDN'T GIVE AND THE PHYSICIAN TRIED TO MOVE THE WIRE FORWARD AND BACK BUT IT WOULD NOT MOVE. THEY HAD TO PULL THE DEVICE AND WIRE OUT SIMULTANEOUSLY. ONCE WIRE WAS FINALLY PULLED OUT OF DEVICE (OUTSIDE PATIENTS BODY) WE ASSESSED THE WIRE. THE WIRE FELT ROUGH TOWARDS THE DISTAL TIP. OTHERWISE, NO OBVIOUS VISUAL ISSUES WITH THE WIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: TWO PHYSICIANS ATTEMPTED TO WITHDRAW THE SAFARI WIRE POST VALVE DEPLOYMENT. WIRE AND DELIVERY SYSTEM WERE WITHDRAWN AS ONE. WHAT IS THE NEXT COURSE OF ACTION?: WIRE REPLACEMENT. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: EXPECTED TO FULLY RECOVER. DEVICE 1: UPN H74939407XS0, MODEL NUMBER 39407XS0, LOT OR SERIAL NUMBER (B)(4). WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. QUESTION: WHAT WAS THE DEGREE AND SHAPE OF THE CALCIUM AT THE ANNULUS? ANSWER: N/A. QUESTION: WHAT WAS THE DEGREE OF TORTUOSITY AT THE AORTIC ARCH? ANSWER: NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710166 ↗
• MalfunctionJan 11, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: I WAS ADVISED THAT THERE WAS RESISTANCE AGAIN FELT WHEN WITHDRAWING THE SAFARI WIRE WHICH THE PHYSICIAN DESCRIBED AS HAVING A 'CATCH' ON THE CURVE OF THE WIRE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION: COMPLAINT SUMMARY: IT WAS REPORTED THAT THE GUIDEWIRE BECAME STUCK. PROCEDURE SUMMARY: THE ELECTIVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS INDICATED FOR SEVERE AORTIC STENOSIS. VASCULAR ACCESS WAS OBTAINED VIA A RIGHT FEMORAL ARTERY ACCESS SITE. A SAFARI2 SMALL CURVE GUIDEWIRE WAS POSITIONED IN THE LEFT VENTRICLE. A NON-BSC VALVE DELIVERY SYSTEM WAS ADVANCED AND THE NON-BSC VALVE WAS SUCCESSFULLY IMPLANTED TO TREAT THE NATIVE AORTIC ANNULUS. THE PHYSICIAN PULLED THE SAFARI2 GUIDEWIRE BACK INTO THE NON-BSC VALVE DELIVERY SYSTEM, BUT FELT RESISTANCE. THE PHYSICIAN USED A LOT OF FORCE BEFORE THE PHYSICIAN WAS FINALLY ABLE TO PULL THE SAFARI2 GUIDEWIRE ALL OF THE WAY OUT OF THE NON-BSC VALVE DELIVERY SYSTEM. BOTH THE NON-BSC VALVE DELIVERY SYSTEM AND SAFARI2 GUIDEWIRE WERE REMOVED FROM THE PATIENT THE PROCEDURE WAS ENDED. PATIENT STATUS: NO PATIENT COMPLIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137363 ↗
• MalfunctionDec 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: : DURING THE CASE, THE SAFARI WIRE BECAME FRAYED, THE PROCEDURE WAS COMPLETED AND THE WIRE WAS REMOVED IN ITS ENTIRETY. WHAT IS THE NEXT COURSE OF ACTION?: FINISHED THE CASE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PROCEDURE DATE: UNKNOWN. ADDITIONAL INFORMATION RECEIVED DECEMBER 14, 2022: THE WIRE NEVER ENTERED THE PATIENT'S BODY, WHEN THEY PULLED THE WIRE OUT OF THE COIL, THE WIRE WAS FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996377 ↗
• MalfunctionDec 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE DIFFERENT TAVI PROCEDURES IDENTIFIED IN THE EVENT DESCRIPTION. MEDWATCH REPORTS 2126666-2022-00047 AND 212666-2022-00048 CAPTURE THE TWO ADDITIONAL PROCEDURES. EVENT DESCRIPTION: I HAVE BEEN TOLD THAT IN AT LEAST 3 DIFFERENT TAVI PROCEDURES, THE SAFARI WIRE XS WAS USED AND FRACTURED, CATCHING ON THE SHEATH ON THE WAY OUT AND IN ONE SEPARATE PROCEDURE ALSO LATCHED TO HEART TISSUE ON THE WAY OUT. I WAS NOT PRESENT AT ANY OF THESE EVENTS AND HAVE NOT BEEN ABLE TO GET FURTHER DETAILS AT THIS STAGE. THERE WERE MULTIPLE LOT NO'S INVOLVED AS ADVISED BY THE NURSE COMMUNICATING THE PROBLEM. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNABLE TO OBTAIN MORE INFORMATION. WAITING FOR THE PHYSICIAN TO GET BACK TO ME. WHAT IS THE NEXT COURSE OF ACTION?: GO TO THE HOSPITAL TO INVESTIGATE THE BOXES THAT WERE RELATED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION PROVIDED ON DECEMBER 14, 2022: DO YOU KNOW IF ANY OF THESE CASES WERE REPORTED AS COMPLAINTS PREVIOUSLY? THIS WAS THE FIRST REPORTED INCIDENTS THAT I HAVE BEEN ALERTED TO. WHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980181 ↗