SAFARI2™ H74939406S0Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729887607), received between Oct 9, 2019 and Jan 29, 2026 — classified as 3 deaths, 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (14 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 30 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 28, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: TAVI PROCEDURE WITH MEDTRONIC VALVE EVOLUTE FX 29 IN A BICUSPIDE VALVE USING A SAFARI WIRE SMALL. AT THE END OF THE PROCEDURE, THE SAFARI WIRE GOT STUCK, IMPOSSIBLE TO REMOVE - FINALLY WHEN PULLING VERY HARD, THEY SUCCEEDED BUT AT THE TIP OF THE WIRE SOME TISSUE WAS OBSERVED. THIS TISSUE IS SENT TO PATHOLOGY FOR ANALYSIS. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: PULLING VERY HARD ON THE WIRE WHAT IS THE NEXT COURSE OF ACTION?: ASKING THE ENGINEERS TO ANALYSE THE TIP OF THE SAFARI WIRE PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. 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: COMPLAINT OCCURED AT THE END OF THE PROCEDURE. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: UNKNOWN. QUESTION: WHERE IN THE PATIENT ANATOMY WAS THE DIFFICULTY ENCOUNTERED? ANSWER: NO. QUESTION: WAS THERE A DEVICE INTERACTION WITH ANOTHER DEVICE? IF YES, PLEASE EXPLAIN AND PROVIDE OTHER PRODUCT DETAILS: ANSWER: MEDTRONIC EVOLUTE FX 29

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099413 ↗
• MalfunctionMar 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: THE GUIDEWIRE BENT, THUS PREVENTING THE MATERIAL FROM ADVANCING AND ALTOGETHER DISMANTLING THE GUIDEWIRE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? REPLACING THE DEVICE. WHAT IS THE NEXT COURSE OF ACTION? REPLACE THE FAULTY DEVICE. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO. WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. QUESTION: HOW WAS THE PROCEDURE COMPLETED - WERE ANY DEVICES EXCHANGED (IF YES, PLEASE SPECIFY)? ANSWER: WITH ANOTHER SAME DEVICE. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: UNKNOWN. QUESTION: WAS THERE DIFFICULTY INSERTING THE DEVICE INTO THE INTRODUCER? ANSWER: NO. QUESTION: WAS THERE DIFFICULTY REMOVING THE DEVICE THROUGH THE INTRODUCER? ANSWER: NO. QUESTION: WHAT WAS THE SUSPECTED CAUSE OF THE REPORTED EVENT? ANSWER: UNKNOWN. MEDIA QUESTIONS: QUESTION: WAS ANY IMAGING PERFORMED (ANGIO, CINE, CT, 3MENSIO)? IF YES, PLEASE NOTE WHAT TYPE OF ANONYMIZED MEDIA IS AVAILABLE AND WHERE IT IS LOCATED: ANSWER: NA. ADDITIONAL INFORMATION RECEIVED 25MAR2025: QUESTION: THERE'S NO MENTION OF A CUT OR FRACTURED MATERIAL IN THE EVENT DESCRIPTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707362 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: SAFARI GUIDE DAMAGED WITH DISCONNECTED COILS -> PRE-DILATION BALLOON EXTRACTED. ADDITIONAL INFORMATION: TYPE OF EVENT: BROKEN/DEFECTIVE. HAS THE INCRIMINATED SAMPLE BEEN KEPT? YES. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 19MAR2025: DESPITE MULTIPLE ATTEMPTS, NO RESPONSES WERE RECEIVED TO OUR REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT. THIS REPORT IS BEING FILED IN GOOD FAITH BASED ON THE EVALUATION OF THE WIRE RECEIVED ON 17MAR2025, WHICH PRESENTED FRACTURE/SHEAR DAMAGE TO THE COIL AND CORE WIRE. MULTIPLE ATTEMPTS WERE SENT TO THE DISTRIBUTOR TO OBTAIN FURTHER EVENT DETAILS; HOWEVER, THE DISTRIBUTOR REPORTED, DESPITE MULTIPLE ATTEMPTS, NO RESPONSES WERE RECEIVED TO OUR REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696697 ↗
• MalfunctionApr 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: DURING PROCEDURE, TECHNICIAN OPENED STERILE PACK AND HANDED OVER THE WIRE TO THE PHYSICIAN. BEFORE INSERTION AND WHILE PURGING HE REALIZED THAT THE WIRE TIP IS COMPLETELY DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089332 ↗
• MalfunctionApr 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: DURING PROCEDURE, TECHNICIAN OPEN STERILE PACK AND HAND OVER THE WIRE TO THE PHYSICIAN. BEFORE INSERTION AND WHILE PURGING HE REALIZE THAT THE WORE TIP IS COMPLETELY DAMAGED. ADDITIONAL INFORMATION RECEIVED MARCH 13, 2024: QUESTION: WHEN DID THE DAMAGE OCCUR? ANSWER: DURING REMOVAL OF THE WIRE FROM THE HOOP QUESTION: WHAT IS MEANT BY WHILE PURGING'? ANSWER: FLUSHING WITH NORMAL SALINE QUESION: CAN YOU CONFIRM THE ISSUE OCCURRED PRIOR TO USE, NO PATIENT CONTACT? ANSWER: PRIOR TO USE QUESTION: WAS THERE DAMAGE NOTED TO THE PACKAGING OR PRODUCT PRIOR TO OPENING THE PACKAGE? ANSWER: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080762 ↗
• MalfunctionOct 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: A TAVI WITH AN ACURATE NEO 2 SIZE L WAS PERFORMED. THE VALVE WAS SUCCESSFULLY ADVANCED, PLACED AND RELEASED AND THE DELIVERY SYSTEM WAS REMOVED AS INTENDED. DURING THE FINAL WITHDRAWAL OF THE SAFARI GUIDEWIRE, IT WAS FOUND THAT THE DISTAL PORTION REMAINED ENTRAPPED WITHIN THE MITRAL SUBVALVULAR APPARATUS, WITH DIFFICULTIES TO RETRIEVE IT BY SIMPLE TRACTION. A MORE ENERGETIC TRACTION WAS THEN PERFORMED, ASSISTED WITH PROTECTION AND SUPPORT BY GUIDE CATHETER AND SNARE SYSTEM. NO COMPLICATIONS WERE FOUND AT THE END OF PROCEDURE. 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. ADDITIONAL INFORMATION: QUESTION: DID THE END USER MONITOR THE WIRE POSITION THROUGHOUT THE PROCEDURE FOR PROPER PLACEMENT OF THE CURVE AND DISTAL TIP? ANSWER: YES, THE END USER MONITORED THE WIRE POSITION FOR THE FULL DURATION OF THE PROCEDURE. QUESTION: WAS THERE ANY RESISTANCE NOTED PRIOR TO THE FINAL WITHDRAWAL? ANSWER: RESISTANCE WAS NOTED AFTER FIRST FINAL WITHDRAWAL ATTEMPT. QUESTION: WHAT DOES THE END USER BELIEVE CAUSED THE DISTAL PORTION OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012324 ↗
• MalfunctionSep 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: WHEN ADVANCING THE INSERTION AID OF THE WIRE, THE WIRE COULD NOT BE MOVED, AFTER THE PHYSICAN HAD APPLIED FORCE TO GET THE INSERTION AID, YOU COULD SEE THAT THE WIRE TIP WAS BENT AND TORN. A NEW WIRE WAS USED BECAUSE THE DEFECT OF THE WIRE HAD BEEN NOTICED BEFORE INSERTION INTO THE PATIENT. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NO TROUBLESHOOTING STEPS NECESSARY PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS THE PATIENT IS DOING VERY WELL AND THE IMPLANTATION WENT SMOOTHLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699997 ↗
• MalfunctionMay 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SHREDDED GUIDEWIRE DURING A TAVI PROCEDURE. CLINICAL CONSEQUENCES: THE GUIDE WAS WITHDRAWN. WE HAD TO CUT THE WIRE WITH A FORCEPS. REPLACEMENT OF THE GUIDE. PROCEDURE COMPLETED WITHOUT ANY CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953371 ↗
• MalfunctionMay 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: DURING THE PREPARATION THE NURSE SAW THE KINKED WIRE TIP IT WAS REPORTED THE PRODUCT WAS NOT USED DURING THE PROCEDURE. PATIENT PRESENT AT TIME OF EVENT?: NO. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS . IT WAS REPORTED THE PRODUCT WAS NOT USED DURING THE PROCEDURE. 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 16847974 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: ON (B)(6) 2023, DURING THE INDEX PROCEDURE, THE SUBJECT EXPERIENCED COMPLETE HEART BLOCK AFTER PLACEMENT OF SAFARI 2 GUIDEWIRE INTO THE LEFT VENTRICLE PRIOR TO THE BALLOON AORTIC VALVULOPLASTY. -OF NOTE, SINCE COMPLETE HEART BLOCK WAS NOTED DUE TO SAFARI 2 GUIDEWIRE PRIOR TO THE PLACEMENT OF STUDY DEVICE, THE EVENT WAS CONSERVATIVELY ASSESSED TO BE RELATED TO SAFARI 2 GUIDEWIRE. FOLLOWING BALLOON VALVULOPLASTY, STUDY DEVICE ACURATE PRIME AORTIC VALVE XL WAS DEPLOYED. POST DILATION WAS NOT PERFORMED. -THE SUBJECT WAS ON RAPID VENTRICULAR PACING (TEMPORARY PACEMAKER). SUBSEQUENTLY, TRANSTHORACIC ECHOCARDIOGRAM IMAGES REVEALED EXCELLENT VALVE PLACEMENT WITH TRIVIAL PERIVALVULAR REGURGITATION. ON (B)(6) 2023, ELECTROPHYSIOLOGY (EP) WAS CONSULTED AND RECOMMEND FOR DUAL CHAMBER PACEMAKER. ON (B)(6) 2023, ON THE SAME DAY OF INDEX PROCEDURE, THE SUBJECT WAS IMPLANTED WITH DUAL CHAMBER PERMANENT PACEMAKER AND TEMPORARY PACEMAKER WAS REMOVED. PER EDC, THE INDICATION OF PPM WAS 3RD DEGREE AV BLOCK. PER EP NOTES, THE SUBJECTS PACED QRS WAS NOT AT THE BEST, PROBABLY DUE TO DAMAGED CONDUCTION POST TAVR. THERE WAS GOOD SENSING/PACING THRESHOLD/IMPEDANCE OF BOTH LEADS. NO NEW AR

  Patient problems: Heart Block

  MAUDE report 16665427 ↗
• MalfunctionFeb 22, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT: THE GUIDE CATCHES IN THE SHAFT. NO CONSEQUENCE OR IMPACT TO PATIENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 9, 2023 REPORTING THE GUIDEWIRE IS STUCK INSIDE THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418537 ↗
• MalfunctionFeb 7, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT : DURING THE TAVI PROCEDURE, THE GUIDE HANGS UP IN THE SHEATH. FIRST ACTION(S) TAKEN: USING ANOTHER GUIDE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: "THE VALVE MUST BE REMOVED BECAUSE THE SAFARI WAS STUCK IN THE VALVE AND ALL THE PROCEDURE MUST BE RESTARTED AT THE BEGINNING, EVERYTHING MUST BE REMOVED." THERE WAS NO NEGATIVE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311974 ↗
• MalfunctionJan 27, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT: ACURATE NEO DELIVERY SYSTEM WAS STUCK ON THE SAFARI2 GUIDEWIRE DURING IMPLANTATION. AS A RESULT THE VALVE WAS IMPLANTED SUCCESSFULLY AND THE DS REMOVED TOGETHER WITH SAFARI GUIDEWIRE. BEFORE THE PROCEDURE HCP FORMED ADDITIONALLY THE GUIDEWIRE. DEVICE COULD NOT BE RETURNED BECAUSE OF THE LOCAL REGULATORY RESTRICTIONS. DID ANY PATIENT HARM OCCUR? NO. WAS BAV PERFORMED? YES. ASSOCIATED WITH LABELED USE? YES. ACTION TAKEN TO RESOLVE: NONE. PATIENT STATUS POST PROCEDURE/EVENT: NO NOTABLE COMLICATIONS. PATIENT COMPLICATIONS: NONE. WHEN DID EVENT OCCUR? DURING VALVE IMPLANTATION. AFTER DEPLOYMENT OF THE PROXIMAL FILTER, WAS THERE DIFFICULTY MANEUVERING AND POSITIONING THE ARTICULATING SHEATH? NO. WAS THERE DIFFICULTY ADVANCING THE DISTAL FILTER #3 HUB FORWARD? YES. DID THE DISTAL FILTER FULLY EXPAND AND APPOSE TO THE VESSEL WALL? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259426 ↗
• MalfunctionNov 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: AFTER DILATATION WITH AN 21 MM TRUE DILATATION BALLOON THE UPPER LAYER LOOSES FROM THE WIRE. NO PATIENT HARM. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: THE PROCEDURE WAS SUCCESSFULLY CLOSED. ADDITIONAL INFORMATION RECEIVED OCTOBER 24, 2022 REPORTING THE ISSUE OCCURED AT THE END OF THE PROCEDURE WHEN THE BALLOON WAS WITHDRAWN AFTER POST-DILATATION, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE REMOVED FROM THE PATIENT IN A NORMAL WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735431 ↗
• MalfunctionSep 28, 2022Entrapment of Device; Material Split, Cut or Torn; Entrapment of Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE WIRE WAS PULLED BACK INTO THE EDWARDS VALVE DELIVERY SYSTEM BUT HAS GOT STUCK AND FORCE WAS USED TO PULL THE WIRE ALL THE WAY OUT OF THE EDWARDS VALVE DELIVERY SYSTEM AND IN DOING SO HAVE CAUGHT THE TIP OF THE SAFARI WIRE ON SOMETHING IN THE EDWARDS SYSTEM AND IT HAS 'DECOILED' THE TIP OF THE WIRE. IT WAS ADVISED BY THE EDWARDS REPRESENTATIVE AT THE CASE TO NOT PULL THE WIRE THROUGH THE DEVICE BUT REMOVE THE DEVICE WHILST STILL OVER THE WIRE AND THE TIP OF THE WIRE IS IN THE LV. THE DOCTOR SAID HE DID NOT THINK OF IT AS AN ISSUE WITH THE WIRE BUT THE EDWARDS TAVI DELIVERY SYSTEM. NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION REPORTED THE VALVE WAS SUCCESSFULLY DEPLOYED AND THE WIRE WAS REMOVED WITH NO PATIENT COMPLICATIONS AND NO FURTHER ACTION REQUIRED. THE ISSUE OCCURRED DURING WITHDRAWAL/CLOSURE. THE WIRE SEEMED TO BE STUCK/LOCKED ON THE WIRE. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE FROM THE DELIVERY SYSTEM WITH MUCH FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500912 ↗
• MalfunctionMar 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE WIRE WAS INSERTED INTO THE INTRODUCER IN THE GROIN, SO WAS INSIDE THE PATIENT AT THE TIME OF THE EVENT, BUT MAY OR MAY NOT HAVE HAD VESSEL WALL CONTACT. NO VASCULAR DAMAGE NOTED AND THE WIRE WAS REMOVED AND A NEW WIRE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: YES. QUESTION: ARE ANY PATIENT STATUS UPDATES AVAILABLE? ANSWER: NO. QUESTION: DESCRIBE ANATOMY (BICUSPID, GOTHIC ARCH, ACUTE BEND, HORIZONAL AORTA, DEGREE OF CURVATURE ETC)? ANSWER: NORMAL ANATOMY. QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: UNKNOWN. QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER: WHEN THE J-STRAIGHTENER WAS PULLED BACK THE WIRE UNCOILED. ADDITIONAL INFORMATION PROVIDED VIA EMAIL ON FEBRUARY 23, 2022: YOU NOTE THAT THE WIRE WAS INSERTED IN THE INTRODUCER IN THE GROIN. WITH THIS IN MIND, WHEN EXACTLY WAS THIS DAMAGE NOTICED UPON INSERTION? THE DAMAGE TO THE WIRE WAS NOTED WHEN THE J-STRAIGHTENER WAS PULLED BACK , THIS AFTER A FEW CM OF INSERTION OF THE WIRE. A. AT WHAT POINT IN THE PROCEDURE WAS THE SAFARI2 REMOVED FROM THE PATIENT? THE DAMAGED SAFARI WIRE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688838 ↗
• MalfunctionMar 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE COIL HAS BROKEN. - TIP OF WIRE ALREADY SLIGHTLY BENT (DURING PREPARATION), WIRE IN PATIENT AND GUIDE CATHETER NOT TO BE ADVANCED OVER THE BROKEN COIL (DURING PROCEDURE), FOR WHICH TO CHANGE THE WIRE. - WIRE HAS BEEN IN PATIENT - SUCCESSFULLY CLOSED PROCEDURE - NO OTHER COMPLICATIONS. ADDITIONAL INFORMATION REPORTED THAT THE PROCEDURE WAS COMPLETED WITH EXCHANGE OF A NEW WIRE FROM THE BOX. NO PATIENT COMPLICATIONS. PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684856 ↗
• DeathFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE TIME OF THIS REPORT IT WAS REPORTED THERE IS NO KNOWN RELATIONSHIP BETWEEN THE SAFARI2 DEVICE AND THE ADVERSE EVENT. ADDITIONALLY, IT WAS REPORTED THERE WAS NO MALFUNCTION RELATED TO THE SAFARI2 DEVICE. CARDIAC PERFORATION, TAMPONADE, PERICARDIAL EFFUSION AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE SAFARI2 GUIDEWIRE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU). BASED ON THE INFORMATION PROVIDED TO DATE, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT. SINCE CARDIAC PERFORATION, TAMPONADE, PERICARDIAL EFFUSION AND DEATH WERE REPORTED AND THE RELATIONSHIP OF THE STUDY DEVICE TO THE REPORTED EVENT CANNOT BE EXCLUDED AT THIS TIME, THIS REPORT IS BEING FILED AS A PREDISPOSITION TO REPORT RATHER THAN NOT REPORT. EVENT DESCRIPTION: PLEASE PROVIDE A BRIEF SUMMARY OF THE EVENT THAT INCLUDES ANY ADDITIONAL DETAILS THAT YOU HAVE NOT ALREADY PROVIDED: PATIENT RECEIVED A TAVI ON (B)(6)WITH A PROTICO DEVICE DIAM 27 DURING THE IMPLANT A SAFARI WIRE LOT N[?] 6550707 + SENTINEL PROTECTION LOT N[?] 26906647 DEVICE WERE USED. PATIENT WAS UNDER SEDATION DURING THE PROCEDURE AND EVERYTHING WENT WELL, ONLY AF

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 13416568 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN ELECTIVE TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE FOR SEVERE AORTIC STENOSIS UNDER CONSCIOUS SEDATION AND LOCAL ANAESTHESIA VIA THE RIGHT FEMORAL ARTERY USING A 14FR ISLEEVE (LOT NO. 25415962). A SAFARI2 SMALL CURVE WIRE WAS POSITIONED IN THE LEFT VENTRICLE VIA THE PIGTAIL CATHETER. A BALLOON VALVULOPLASTY WAS PERFORMED WITH A NUMED 22MM BALLOON. AN ACURATE NEO2 MEDIUM VALVE SN. (B)(4) WAS THEN POSTIONED OVER THE SAFARI WIRE AND DELIVERED TO THE AORTIC VALVE ANNULUS. THE DEVICE WAS DEPLOYED GRADUALLY UNDER FLUOROSCOPIC GUIDANCE (PACED AT 100BPM) TO HELP WITH POSITIONING. THE VALVE WAS SUCCESSFULLY DEPLOYED AS PER DFU. THE PATIENT THEN BECAME HYPOTENSIVE DESPITE MULTIPLE BOLUSES OF METARAMINOL. URGENT CORONARY ANGIOGRAM OF THE LEFT MAIN CORONARY ARTERY DEMONSTRATED NO CORONARY OBSTRUCTION. TRANSTHORACIC ECHOCARDIOGRAPHY DID NOT DEMONSTRATE AORTIC REGURGITATION HOWEVER DID NOTE A MODERATE PERICARDIAL EFFUSION FEATURES OF CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED WITHOUT ANY COMPLICATIONS. THERE WAS INITIAL 250ML DRAINAGE OF BLOOD AND A FURTHER 100ML IN THE DRAINAGE VACUUM BOTTLE AT THE END OF THE CASE. THE PATIENT WAS STABLE. FINAL RESULT

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12195899 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER EMAIL, IT WAS REPORTED THAT: ATTEMPTED TO CLOSE A FAILED SURGICAL LIGATION. TRANSEPTAL WAS DONE, A DOUBLE CURVE LOT 26266917 WAS INSERTED INTO LEFT ATRIUM. THE MD CHOSE TO USE A 4FRENCH CORDIS CATHETER TO HELP NAVIGATE INTO THE SMALL OSTIA. HE THEN CHOSE A SAFARI 2 WIRE LOT 11209610 TO HOLD POSITION IS THE LAA IN ORDER TO NAVIGATE THE WAS INTO THE OSTIA. THIS WAS ATTEMPTED AND IT APPEARED THE WAS WAS IN THE OSTIA, ONCE THE CORDIS CATHETER AND THE SAFARI WERE PULLED THE SHEATH WAS NOTED ON ECHO TO NOT BE IN THE LAA. THE MD ATTEMPTED THE SAME MANEUVER AGAIN, UPON DOING A CONTRAST INJECTION THIS TIME IT WAS NOTED ON FLUORO THAT THE WIRE HAD PERFORATED THE WALL OF THE LAA. 200 PRO TAMING WAS GIVEN, THE PATIENTS BP DROPPED, THE CHEST WAS PREPPED FOR PERICARDIOCENTESIS AND SURGEONS WERE CALLED. THE PATIENT BEGAN TO STABILIZE, NOT PERICARDIOCENTESIS WAS PERFORMED, THE SURGEON AND DOCTOR AGREED IT BEST TO WATCH THE PATIENT OVERNIGHT AND NOT INTERVENE. *BASELINE TRIVIAL EFFUSION WAS NOTED AT START OF PROCEDURE, TRIVIAL EFFUSION NEVER CHANGED ON TEE, TRANSVERSE SINUS FLUID STATUS DID INCREASE POST PERFORATION BUT NORMALIZED. PT WENT TO ROOM IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 11132736 ↗
• MalfunctionDec 9, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: THE PHYSICIAN HAVE REPORTED THAT ,THE PREPARATION OF THE SAFARI2 SMALL WIRE. WAS DONE BY HOSPITAL STAFF ACCORDING IFU .NO TR WAS PRESENT ( NO ACCURATE IMPLANTATION) ,THEY USE THE WIRE FOR ALL TAVI IMPLANTATION. BEFORE THE INSERTION THE SAFARI WIRE SHOWED NO DAMAGE LIKE A KINKING, OR BENDING DURING THE INSERTION TROUGH THE SHEATH (MDT) THE PHYSICIAN FELT A RESISTANCE AND DECIDED TO REMOVE THE WIRE, AND USE ANOTHER SAFARI WIRE. THE PATIENT WAS STABLE DURING THE FULL SITUATION -NO PAT HARM. NO VASCULAR INJURY. COMPLAINT SUMMARY: THE SAFARI2 GUIDEWIRE WAS INSERTED, AND RESISTANCE WAS FELT BY THE PHYSICIAN DURING ADVANCEMENT. THE GUIDEWIRE WAS REMOVED, AND REPLACED. NO HARM WAS DONE TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED: WAS THE PROCEDURE COMPLETED SUCCESSFULLY?: SUCCESSFUL. DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S). WHAT TROUBLESHOOTING STEPS TOOK PLACE? USE ANOTHER WIRE. WAS THE DEVICE IMPLANTED OR DID AN ATTEMPT TO IMPLANT OCCUR?: NO. PATIENT COMPLICATIONS RELATED TO DEVICE? NO. DID THIS DEVICE HAVE PERFORMANCE ISSUES? YES. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: BENT OR KINKED. WHEN WAS THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978815 ↗
• MalfunctionAug 10, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED BY THE DISTRIBUTOR: EVENT DESCRIPTION: IT WAS REPORTED THAT: THE INTEGRATION OF THE SAFARI WIRE HAS RESOLVED ITSELF. THE TAVI IS WELL ENTERED. WHAT CONDITION WAS THE PATIENT BEING TREATED FOR?: TAVI. WAS THE PROCEDURE COMPLETED SUCCESSFULLY?: SUCCESSFUL. DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S) WHAT TROUBLESHOOTING STEP, IF ANY, RESOLVED THE ISSUE? THE PROCEDURE HAS BEEN SUCCESSFULLY OBTAINED. DID THIS DEVICE HAVE PERFORMANCE ISSUES? YES. WERE THE ISSUES IDENTIFIED OUT-OF-BOX?: NO. DO YOU HAVE A PHOTO, VIDEO, OR SCREENSHOT DEPICTING THE ISSUE?: NO. WAS A PATIENT INVOLVED WITH THIS EVENT?: YES. ARE ANY PATIENT STATUS UPDATES AVAILABLE? PATIENT IS FINE. THIS INCIDENT IS BEING REPORTED DUE TO THE SAFARI GUIDEWIRE THAT WAS RETURNED FOR ANALYSIS PRESENTED A DUCTILE TENSILE OVERLOAD FRACTURE OF THE CORE WIRE NEAR THE DISTAL TIP OF THE GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388395 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: IT WAS REPORTED THAT: SAFARI WIRE BROKE AND INDUCED A PERICARDIAL EFFUSION, WHICH WAS RESOLVED BY PERICARDIAL PUNCTURE. POTENTIAL COMPLICATIONS: SERIOUS INJURY. IF YES, HOW RESOLVED? RESOLVED BY PERICARDIAL PUNCTURE.

  Patient problems: Pericardial Effusion

  MAUDE report 10144101 ↗