SAFARI2™ H74939407XS0Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 08714729887638), received between Jun 17, 2019 and Mar 9, 2026 — classified as 9 deaths, 9 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• 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 ↗
• DeathJun 3, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: DURING THE TAVI PROCEDURE, WE WERE IN THE VALVE RELEASE STAGE IN PART 2. WHEN AN ANESTHESIOLOGIST REPORTED THAT THE PATIENT'S BLOOD PRESSURE WAS DROPPING, AT THAT MOMENT THE CONCERN WAS TO MAINTAIN TENSION AND RELEASE THE VALVE COMPLETELY, WE RELEASED THE VALVE AND THEN THE ECHO DETECTED PERICARDIAL EFFUSION. THE CHANGE WAS MADE; THEY CALLED THE HEART MUSCLE AND OPENED THE PATIENT. BLOOD WAS DETECTED DEEP IN THE LEFT VENTRICLE, THE CATHETER MANAGED TO CONTAIN IT BUT THEN ANOTHER PERFORATION APPEARED IN THE RIGHT VENTRICLE, TEARING THE DISTAL PART OF THE HEART. PATIENT DIED ACCIDENTALLY. LOOKING AT THE FACTS, IMAGES AND WHAT THE APPEAL SAID, THE SAFARI GUIDE WIRE PIERCED THE LEFT VENTRICLE CAUSING ALL OF THIS. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: PERICARDIAL EFFUSION. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? YES. PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION? THE SAFARI GUIDE WIRE ENDED UP PIERCING THE LEFT VENTRICLE AND CAUSING PERICARDIAL EFFUSION AFTER VALVE DEPLOYMENT. MEDICAL OR SURGICAL INTERVENTIONS: A CARDIAC

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 22136193 ↗
• InjuryMay 20, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: PATIENT PRESENTING WITH AS ADMITTED FOR TAVI PROCEDURE. FEMORAL ACCESS: VERY NARROW VESSELS, VASOSPASM SUSPECTED. DIAMETERS DID NOT MATCH THE CT SCAN FROM MYSELF AND CENTER MEASUREMENTS. 7FR SHEATH OCCLUDED DISTAL FLOW. COVERED STENTS PREPARED AND SAFETY WIRES PLACED IN LEFT FEMORAL. TAVI PROCEDURE CONTINUED. ISLEEVE ADVANCED WITH RESISTANCE BUT NOT ABNORMALLY SO. CROSSING ANNULUS WAS EXTREMELY DIFFICULT AND SAFARI WIRE WAS VERY CENTRAL EVEN WHEN PLACED DEEP IN LV. THREE CUSP VIEW CHECKED, RC SLIGHTLY HIGH BUT DID NOT CORRECT, WANTED TO CHECK WITH PARALAX. PRE-DIL DONE WITH 20MM OUTFLO BALLOON. NO PACING. SAFARI WIRE SEEMED TO CORRECT POSITION AFTER THIS AND SIT FLUSH AGAINST THE OUTER CURVATURE. DS ADVANCED TO ANNULAR LEVEL. COMMISURAL ALIGNMENT WAS DONE. ADVANCED TO BOTTOM OF ANNULUS WITH ONLY FORWARDS MOVEMENT. INITIAL POSITION WAS VERY GOOD, AS SEEN ON FLURO, THE SAFARI HAD GOOD POSITION AS WELL. DURING THE DEPLOYMENT OF THE UPPER CROWN, THE VALVE MOVED VENTRICULAR. THERE WAS A LOT OF RESISTANCE TO RETRACT IT. I SUGGESTED MOVING TO OVERLAP TO CHECK IN THE UPPER CROWN WAS CAUGHT UNDER THE LEAFLET. AT THAT POINT THE PATIENT WAS EXTREMELY UNSTABLE AND NEEDED CPR

  Patient problems: Heart Block

  MAUDE report 22055058 ↗
• MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN THE GUIDE WIRE WAS INSERTED, IT ENCOUNTERED RESISTANCE. WHEN IT WAS WITHDRAWN, IT WAS FOUND THAT THE TIP OF THE GUIDE WIRE HAD FRACTURED. AFTER REPLACING IT WITH ANOTHER GUIDE WIRE, THE INSERTION WAS SUCCESSFUL. THE PATIENT CONDITION FOLLOWING PROCEDURE STABLE. ADDITIONAL INFORMATION RECEIVED 31MAR2025: QUESTION: WAS THERE ANY DAMAGE NOTED TO THE SAFARI2 GUIDEWIRE PRIOR TO USE? ANSWER: NO QUESTION: WAS THE INCLUDED J-STRAIGHTENER USED TO INSERT THE SAFARI2 GUIDEWIRE INTO THE HUB OF THE SHEATH PER THE INSTRUCTIONS FOR USE? ANSWER: UNKNOWN QUESTION: IS THIS A NEW USER OR EXPERIENCED USER? ANSWER: UNKNOWN QUESTION: LISTING AND MODEL OF OTHER DEVICES USED DURING THE INSERTION PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. ANSWER: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752296 ↗
• MalfunctionMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE PHYSICIAN CONTACTED ME BECAUSE HE NOTICED THAT THE SAFARI GUIDE'S COATING WAS DETACHED, WHICH MADE IT DIFFICULT TO INTRODUCE ANY OTHER SUPPLIES INTO IT (CATHETER, INTRODUCER, ETC.) 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?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO PHOTO OR VIDEO OF ISSUE: YES QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: NO, THE PHYSICIAN NOTICED WHEN TRY TO USED IT, THAT MAKES DIFFICULT TO PASS THROUGH ANY OTHER DEVICE QUESTION: WHEN SPECIFICALLY DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: BEFORE INTRODUCING, PHYSICIAN FEEL RESISTANCE ACROSS ANY OTHER DEVICE QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER: DISTAL TIP (NOT THE CURVE OF SAFARI) ADDITIONAL INFORMATION RECEIVED 12MAR2025: QUESTION: THE ATTACHED REPORT INDICATES THE WIRE WAS DISPOSED. ARE THERE ANY ADDITIONAL IMAGES AVAILABLE OF THE WIRE? ANSWER: NO QUESTION: THE IMAGE BELOW THAT SHOWS THE STRETCHED COIL MATERIAL, IS THAT PIECE FRACTURED/DETACHED MATERIAL (ARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677941 ↗
• MalfunctionJan 23, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: PHYSICIAN STATED THE DEVICE WAS ADVANCED ACROSS THE VALVE IN A PIGTAIL CATHETER. THE PIGTAIL WAS REMOVED AND THE EDWARDS TAVR VALVE DELIVERY SYSTEM WAS ADVANCED OVER THE DEVICE. THE VALVE WAS DEPLOYED AND THE DEVICE WOULD NOT RETRACT INTO THE DELIVERY SYSTEM. IT WOULD ADVANCE BACK OUT OF THE DEVICE BUT NOT RETRACT FULLY IN THE DEVICE. THE DEVICE AND THE DELIVERY SYSTEM WERE REMOVED SIMULTANEOUSLY AND IT WAS NOTED OUTSIDE THE BODY UPON INSPECTION THE DEVICE HAD UNRAVELED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? PLEASE SEE ABOVE. WHAT IS THE NEXT COURSE OF ACTION? NOT APPLICABLE. 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: ANY RESISTANCE ENCOUNTERED DURING ADVANCEMENT THROUGH ANATOMY? ANSWER: NO. QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: NO. 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: DURING REMOVAL. QUESTION: WHERE SPECIFICALLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218696 ↗
• MalfunctionNov 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: ONE OF THE ROPES USED ON (B)(6) 2024 IN A PROCEDURE WAS UNUSABLE BECAUSE ITS FLEXIBLE TIP WAS STUCK INSIDE THE TIP. ONLY WITH A LOT OF EFFORT WAS IT POSSIBLE TO MOBILIZE IT AND ITS OUTER LAYER FRAYED, PREVENTING ITS USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798321 ↗
• MalfunctionNov 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: DURING THE ACCESS TO LA, SPECIFICALLY IN THE TRANSEPTAL PUNCTION THE SAFARI WIRE THE COIL OF THE SAFARI WIRE IS DAMAGED, IT COMES OFF AND OPENS AS IF STRETCHING. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? REMOVE THE GUIDE AND TRY USING ANOTHER ALTERNATIVE GUIDE. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. QUESTION: PHOTO OR VIDEO OF ISSUE? ANSWER: YES. QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: MAYBE DURING THE INSERTION. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: I DON´T KNOW. QUESTION: WHEN SPECIFICALLY, DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: DURING THE PROCEDURE. QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER: WHEN THE DOCTOR ACROSS THE INTERACURICULAR SEPTUM. QUESTION: DEVICE/PROCEDURE OUTCOME: ANSWER: PROCEDURE COMPLETED VIA ALTERNATIVE METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774891 ↗
• DeathNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: AFTER PRE-DILATION, THE PATIENT BEGINS WITH AN ABRUPT DROP IN BLOOD PRESSURE AND ENTERS AORTIC INSUFFICIENCY AND CONVULSIVE STATE. THE CLINICAL TEAM BEGINS TO BREATHE AND THE PATIENT ENTERS CARDIORESPIRATORY ARREST. THE POSITION AND INSERTION OF THE VALVE IS QUICKLY DEFINED, AND IT IS RELEASED CORRECTLY, IN CORRECT POSITION, THINKING THAT THE PATIENT COULD COME OUT OF THE CARDIORESPIRATORY ARREST, BUT HE HELD ON. CPR MANEUVERS BEGIN FOR APPROXIMATELY 5-8 MINUTES, PATIENT IS INTUBATED. PERICARDIAL EFFUSION SECONDARY TO PRESUMED PERFORATION OF THE VENTRICLE IS VISUALIZED UNDER ULTRASOUND. TEAM CONTINUES PERFORMING CPR AND DELIVERING VASOACTIVE DRUGS TO THE PATIENT. WHEN REVIEWING IMAGES AFTER THE EVENT, IT IS EVIDENT THAT AFTER PRE-DILATION, SAFARI ADOPTS A HORIZONTAL POSITION AND DOCTORS THEORIZE THAT IT WAS PROBABLY AT THAT MOMENT WHERE THE PERFORATION OCCURRED. CPR IS MAINTAINED FOR ALMOST AN HOUR. PATIENT PRESENT AT TIME OF EVENT: YES. PATIENT COMPLICATIONS: PERICARDIAL EFFUSION, DEATH IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? NO. MEDICAL OR SURGICAL INTERVENTIONS: CPR, INTUBATION, FIBRILLATION IS A

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20689060 ↗
• MalfunctionSep 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED 03OCT2023: QUESTION: WHAT IS THE TYPE/BRAND/SIZE OF BALLOON CATHETER USED DURING THE PROCEDURE? ANSWER: ZMED. QUESTION: WAS THE ORIGINAL BALLOON CATHETER USED TO COMPLETE THE PROCEDURE? ANSWER: YES. QUESTION: WAS THE CURVE OF THE SAFARI2 GUIDEWIRE CONSTRAINED WITHIN A CATHETER DURING INSERTION INTO AND WITHDRAWAL FROM THE BODY OR TREATMENT SITE? ANSWER: AFTER THE WIRE UNRAVELED NO INSERTION INTO A CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269379 ↗
• MalfunctionAug 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  GUIDE DID NOT COME OUT OF THE SNAIL AND WHEN IT WAS REMOVED IT WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940175 ↗
• MalfunctionJul 24, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: WE USED SAFARI EXTRA SMALL GUIDE WIRE, WHICH GOT STUCK IN THE NAVITOR PROSTHESIS DELIVERY SYSTEM. IT WAS LATER OBSERVED THAT THERE WAS A DEFECT AT THE DISTAL END THAT PROVED "TEARING" OF THE COATING. THE PROCEDURE WAS REPORTED TO BE A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818280 ↗
• DeathJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: BEFORE THE PROCEDURE, AN EVALUATION OF THE CASE WAS PERFORMED AND THE STEP-BY-STEP OF THE VALVE RELEASE WAS REVIEWED. IT WAS DECIDED THAT IT WOULD BE A MEDIUM VALVE, PRE DILATION WITH A SEMI COMPLIANT BALLOON (THE ONE AVAILABLE IN THE HOSPITAL) SIZE 20X45 ACCORDING TO THE EVALUATION OF THE REPORT. THE PROCEDURE BEGAN WITH TRANSFEMORAL, LEFT AND RIGHT FEMORAL PUNCTURES, GUIDED BY ULTRASOUND. AFTER THE PUNCTURES WERE PERFORMED AND THE VASCULAR CLOSURE DEVICES (PROGLIDE) WERE POSITIONED, THE PIGTAIL CATHETER WAS RAISED TO FILM THE AORTIC ARCH. AFTERWARDS, THE AL1 CATHETER WAS RAISED WITH THE STRAIGHT-TIPPED WIRE TO ATTEMPT TO CROSS THE PATIENT'S NATIVE VALVE. AFTER TWO ATTEMPTS WITH THE STRAIGHT TIP GUIDE, HE MANAGED TO CROSS THE VALVE. CHANGED THE STRAIGHT TIP GUIDE FOR THE SAFARI EXTRA SMALL GUIDE. DECIDED TO PRE-DILATE WITH THE CRYSTAL BALLOON CATHETER SIZE 20X45. PRE-DILATION PERFORMED SUCCESSFULLY AND EFFECTIVELY. TO DATE, THE PATIENT HAD NO HEMODYNAMIC INSTABILITY. THE MIDDLE VALVE WAS RAISED. AFTER THAT, THE POSITIONING OF THE VALVE IN THE IMPLANT PROJECTION VIEW WAS INITIATED. COMMISSURAL ALIGNMENT WAS PERFORMED, AND VALVE ALIGNMENT WAS CONFIRMED IN THE CUSP

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19574254 ↗
• MalfunctionMay 9, 2024Malposition of Device; Malposition of Device

  EVENT DESCRIPTION: TAVI WITH AN ACURATE NEO 2 SIZE L WAS PERFORMED. THE DELIVERY SYSTEM WAS ADVANCED AND POSITIONED AS INTENDED. DURING FINAL RELEASE, THE VALVE MOVED AORTIC. THE VALVE WAS THEN SNARED AND POSITIONED AT THE LEVEL OF THE SINOTUBULAR JUNCTION. A SECOND VALVE (SAPIEN 3 ULTRA 26) WAS THEN ADVANCED AND RELEASED WITH GOOD RESULT. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE: SNARING THE VALVE IN SAFETY POSITION AND ADVANCING/RELEASING A SECOND VALVE (SAPIEN) WHAT IS THE NEXT COURSE OF ACTION ? N/A PATIENT PRESENT AT TIME OF EVENT? YES PATIENT COMPLICATIONS : MIGRATION IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION ? NO MEDICAL OR SURGICAL INTERVENTIONS: PLACEMENT OF A SECOND VALVE (SAPIEN 3 ULTRA 26) PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: EXPECTED TO FULLY RECOVER PHOTO OR VIDEO OF ISSUE: NO QUESTION: WAS THE VALVE RELEASED IN THE INTENDED LOCATION? IF NO, PLEASE SPECIFY ANSWER: YES QUESTION: WAS THERE NEUTRAL TENSION APPLIED TO THE DELIVERY SYSTEM DURING DEPLOYMENT? ANSWER: FORWARD TENSION QUESTION: WAS THE VALVE SNARED? IF SO, WHAT PART OF THE VALVE WAS SNARED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281601 ↗
• DeathApr 26, 2024Material Deformation; Material Deformation

  DURING TAVI, IT WAS NOTED THE PATIENT HAD A VERY SMALL LV. THE SAFARI WIRE BUCKED AT THE APEX AND SEEMED TO SIT VERTICALLY AROUND THE CURVE OF THE APEX, THE PHYSICIAN PULLED THE WIRE BACK THOUGH A PIGTAIL AND REPOSITIONED IT IN THE APEX HOWEVER THE CURVE OF THE WIRE WAS OFF AND WOULDN'T SIT NICELY, I MENTIONED IT LOOKS BENT OR KINKED SO THEY REMOVED IT THROUGH THE PIGTAIL AND IT WAS INDEED KINKED. WE GOT A NEW SAFARI WIRE WHICH SAT NICELY IN THE APEX AND PROCEEDED WITH CASE. POST DEPLOYMENT PATIENT HAD A BEAUTIFUL RESULT. 30 MINUTES LATER PATIENT COMPLAINED ABOUT CHEST PAIN. THEY DID A TEE AND NOTED A PE. PATIENT WAS TAKEN BACK INTO LAB AND TREAT PE AND AFTER 1 HOUR WAS SENT FOR SURGERY TO MANAGE THE BLEEDING. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: CHANGE WIRE WHAT IS THE NEXT COURSE OF ACTION?: ASSSESS WIRE PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: PERICARDIAL EFFUSION IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION?: THE SAFARI WIRE SEEMED TO BUCKLE IN THE LV CAUSING IT TO PER

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19193512 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION PROVIDED APRIL 23, 2024: QUESTION: WAS THERE ANY TREATMENT OR INTERVENTION PERFORMED? ANSWER: THE ACCURATE PROCEDURE WAS POSTPONED DUE TO THE PERFORATION. QUESTION: EVENT DESCRIPTION STATES NO IMMEDIATE INTERVENTION, BUT OPEN-HEART SURGERY LISTED, DID THE PATIENT GO TO OPEN HEART SURGERY? WHEN WAS THE PATIENT BROUGHT TO OPEN HEART SURGERY? ANSWER: THE PATIENT WENT TO OPEN HEART SURGERY DUE TO THE VENTRICLE PERFORATION STRAIGHT FROM THE CAT LAB. QUESTION: WHAT WAS PERFORMED DURING OPEN-HEART SURGERY? ANSWER: CLOSURE OF VENTRICLE. QUESTION: WHAT IS THE PATIENTS CURRENT STATUS? HAS THE PATIENT FULLY RECOVERED FROM THIS EVENT? ANSWER: PATIENT IS FULLY RECOVERED, AT HOME; QUESTION: HAS THE PATIENT BEEN DISCHARGED FROM THE HOSPITAL? ANSWER: YES. QUESTION: IS THERE ANOTHER PROCEDURE SCHEDULED IN THE FUTURE FOR THE PATIENT? ANSWER: NOT YET. QUESTION: THE INFORMATION INDICATES THAT IN THE PHYSICIAN'S OPINION, NEITHER THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION. WAS IT CONFIRMED VIA IMAGING WHAT CAUSED THE PERFORATION TO THE LEFT VENTRICLE OR HOW WAS THE DEVICE AND/OR PROCEDURE RULED OUT AS THE CAUSE? ANSWER: IT WAS CONFIRMED VIA IMAGE THE

  Patient problems: Cardiac Perforation

  MAUDE report 19165203 ↗
• MalfunctionMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: SAFARI WIRE WAS TAKEN OUT OF THE PACKAGE TO USE DURING A TAVI PROCEDURE. WHEN USING THE J-STRAIGHTENER THAT IS USED TO AID IN THE INSERTION OF THE GUIDEWIRE INTO THE DELIVERY CATHETER, THEY WERE UNABLE TO ADVANCE THE GUIDEWIRE INTO THE DELIVERY CATHETER THROUGH THE J-STRAIGHTENER. THE GUIDEWIRE WAS STUCK AND WHEN THEY TRIED TO RETRIEVE THE GUIDEWIRE, THE GUIDEWIRE UNCOILED THE GUIDEWIRE WENT NOT INTO THE PATIENT, JUST THE J-STRAIGHTENER TOUCHED THE PIGTAIL AND THAT'S WHY SOME BLOOD IS INTO THE STRAIGHTENER. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ANOTHER GUIDEWIRE WAS TAKEN. WHAT IS THE NEXT COURSE OF ACTION?: A NEW GUIDEWIRE USED WITHOUT ANY ISSUE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827714 ↗
• MalfunctionFeb 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE GUIDE WAS STUCK INSIDE THE INTRODUCTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18792683 ↗
• MalfunctionFeb 27, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: THE SAFARI GUIDEWIRE GOT STUCK IN THE MITRAL VALVE PROLONGING THE PROCEDURE WITH INCREASED FLUOROSCOPY AND CONTRAST EXPOSURE. THE SAFARI WAS EVENTUALLY RETRIEVED USING A A1 4FR CATHETER WITH DELICATE PULLING. FORTUNATELY, NO PERICARDIAL EFFUSION WAS OBSERVED. MITRAL REFLUX OCCURRED DURING THE ITERATION BETWEEN THE SAFARI AND THE CHORDS, BUT IT DID NOT PERSIST THEREAFTER. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: CATHETER INSERTION IN ORDER TO MOVE THE SAFARI AND HELP IT TO BE LOOSEN. WHAT IS THE NEXT COURSE OF ACTION?: SAFARI WAS REMOVED FROM PATIENT PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS QUESTION: ARE ANY PATIENT STATUS UPDATES AVAILABLE? ANSWER: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789965 ↗
• MalfunctionJan 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: AFTER THE VALVE DEPLOYMENT, THE SAFARI WAS REPLACED WITH A PIGTAIL INTO THE VENTRICLE. MORE THAN MILD PVL WAS NOTED WHICH REQUIRED A POSTDIL. THE NURSE TRIED TO INTRODUCE THE GUIDEWIRE INTO THE STRAIGHTENER, HOWEVER SHE FELT AN UNUSUAL RESISTANCE. SHE WITHDREW THE SAFARI TO REATTEMPT THE INSERTION YET THE SPRING COIL WAS STUCKED IN BETWEEN THE TUBE AND THE STRAIGHTENER CAUSING THE DETACHMENT OF THE SPRING COIL FROM THE CORE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: REPLACED GUIDEWIRE WITH A NEW ONE PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528423 ↗
• MalfunctionDec 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS IDENTIFIED DURING THE TAVI PROCEDURE THAT THE GUIDE SHOWED A QUALITY DEVIATION THE SITE CLARIFIED THAT THEY IDENTIFIED THE DEFECT WHEN OPENING THE MATERIAL. THE ISSUE OCCURED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE (SAME MODEL). NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18286644 ↗
• DeathOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: PIG POSITIONED AT NCC. COMMISSURAL ALIGNMENT WAS PERFORMED WITH FLUSH PORT 6H AND SYSTEM MANIPULATION. POSITIONING THE VALVE AT THE HEIGHT OF THE PIG. CONTRAST PUMP INJECTION SHOWING THE PIG WAS TOO HIGH. REPOSITIONING THE PIG AND VALVE. NEW CONTRAST INJECTION SHOWING VALVE AT ADEQUATE HEIGHT TO INITIATE RELEASE. OPENING OF KNOB 1A WITH THE UPPER CROWN EXPOSED. CONTRAST INJECTION. VALVE KEPT IN PROPER PLACE. KNOB 1B WITH EXPOSURE OF THE STABILIZING ARCHES. BEFORE THE FINAL RELEASE, A NEW CONTRAST INJECTION WOULD BE MADE, BUT IT WAS NECESSARY TO REPLACE THE CONTRAST IN THE PUMP. AT THIS POINT WE DON'T KNOW IF THERE WAS MOVEMENT BY THE FIRST OPERATOR AND THE VALVE WENT DOWN TOO LOW. THE OPERATOR CHOSE TO TRY TO MOVE THE VALVE A LITTLE UPWARDS DESPITE KNOWING THE RISKS WITH THE UPPER CROWN AND OPEN ARCHES. REPOSITIONED, THE VALVE REMAINED A LITTLE BELOW IDEAL AND IT WAS DECIDED TO FINALIZE THE RELEASE WITH KNOB 2. VALVE RELEASED AND EXPANDED COMPLETELY. A CONTRAST PUMP WAS PERFORMED AND CONTRAST LEAKAGE WITH PERICARDIAL PERFORATION WAS OBSERVED. EMERGENCY MANEUVERS WERE INITIATED WITH PERICARDIAL DRAINAGE AND VISUALIZATION WITH TT ECHO. A CARDIAC SURGEON MADE AN INC

  Patient problems: Cardiac Perforation

  MAUDE report 17964923 ↗