SAFARI2™ H74939407S0Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729887652), received between Jun 28, 2019 and Mar 9, 2026 — classified as 4 deaths, 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (19 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 40 reports, in the reporter's own words as published by the FDA.

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

  EVENT DESCRIPTION : ONCE THE TAVI PROCEDURE WAS COMPLETED, THEY WANTED TO RETRIEVE THE SAFARI WIRE BY USING THE PIGTAIL OUT FROM THE VENTRICLE, BUT THE SAFIRE WIRE WAS STUCK INSIDE THE VENTRICLE - IMPOSSIBLE TO REMOVE. A LONGER PIGTAIL WAS USED TO THE WE COULD PULL HARDER ON THE WIRE, BUT NO MOVEMENTS. FINALLY WE USE ' CUTTING ' OVER THE WIRE AND THE WIRE CAME LOOSE. END GOOD ALL GOOD WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE ? USING CUTTING OVER 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 WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO 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: YES QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: NO 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 DETAIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096950 ↗
• DeathMay 6, 2025Malposition of Device; Malposition of Device

  EVENT DESCRIPTION: ON (B)(6) 2025, DURING TAVI CASE AFTER THE FINAL RELEASE OF THE ACURATE PRIME VALVE 27MM, THE VALVE WAS IMPLANTED AT HIGH POSITION (PROBABLY BECAUSE THERE WAS A RAPH BETWEEN RIGHT AND NON-CORONARY CUSP. HOWEVER, THE CT SCAN ANALYSIS WAS SUBOPTIMAL AND THIS IS NOT 100% CONFIRMED. BEFORE CASE, THE PHYSICIANS WERE ALSO AWARE OF THE RAPHE). THE PHYSICIANS ESTIMATED THAT THE HEMODYNAMIC RESULT NEEDED TO BE IMPROVED, SO THEY DECIDED TO DO POST-DILATATION (IGNORING MY WARNINGS OF THE RISK TO DO POST-DILATATION IN A HIGH POSITION) AND THE VALVE MOVED AORTIC. THEN, AFTER CHECKING THAT THE CORONARY FLOW WAS GOOD, THEY DECIDED TO DO VALVE IN VALVE. AFTER THE VALVE IN VALVE, THE HEMODYNAMICS WAS GOOD. ON (B)(6), THE PATIENT HAD A STROKE AND DISSECTION OF AORTA. ON (B)(6), THE PHYSICIANS ANNOUNCED DEATH. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: DEATH. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? NO. MEDICAL OR SURGICAL INTERVENTIONS: VALVE IN VALVE. PATIENT OUTCOME: DEATH. 23APR2025: THE FOLLOWING INFORMATION RECEIVED VIA A RELATED ACURATE PRIME COMPLAINT INSTIGATED THE NEED FOR A SAFARI2 COMPLAI

  Patient problems: Cardiac Perforation; Stroke/CVA

  MAUDE report 21969568 ↗
• InjuryApr 24, 2025Use of Device Problem; Use of Device Problem

  14MAY2025: ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR: WE HAVE RECEIVED THE FOLLOWING ADDITIONAL EVENT DETAILS: · CASE WAS PERFORMED INDEPENDENTLY - VALVE LOADED BY CERTIFIED PRIME LOADER. · PRE-DIL X3 WITH 23MM BALLOON WITH BALLOON SLIPPING. · FOR INITIAL VALVE POSITIONING PIGTAIL WAS SITTING HIGH AND DS WAS POSITIONED AT LEVEL OF THE PIGTAIL. · VALVE WAS RELEASED IN A HIGH POSITION AND EMBOLIZED FURTHER DUE TO INTERACTION WITH THE SAFARI2 WIRE. · 1ST VALVE WAS LEFT IN HIGH POSITION AND PROCEEDED WITH 2ND VALVE(PRIME) IMPLANTATION - 2ND VALVE IMPLANTED LOW AND WAS UNDEREXPANDED. · POST -DIL PERFORMED WITH 25MM BALLOON - LOOKS TO BE SOME REPOSITIONING ATTEMPTS WITH BALLOON - PATIENT WAS SENT TO SURGERY TO EXPLANT BOTH VALVES. · NO FOLLOW UP REQUIRED / REQUESTED - DIFFICULTIES WITH POSITIONING DUE TO PATIENT ANATOMY. PROCEDURAL ANGIOGRAPHIC MEDIA SHOWING THE INTERACTION OF THE SAFRI2 AND THE ACURATE PRIME VALVE WAS NOT PROVIDED FOR REVIEW. NO FURTHER INFORMATION REGARDING THIS EVENT IS EXPECTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21901549 ↗
• MalfunctionMar 27, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: TAVI PROCEDURE, AORTIC VALVE WAS CROSSED AND SAFARI WIRE IN PLACE NEXT STEP IS TO PERFORM A PREDILATATION OF THE ANNULUS WITH A BIG BALLOON OVER THE SAFARI WIRE. WHEN BRINGING IN THE BALLOON OVER THE SAFARI WIRE, THE BOLLOON DIDN'T WANT TO ADVANCE OVER THE WIRE AND TO RETRIEVE THE BALLOON IT WAS ALSO NOT POSSIBLE ANYMORE. THEY HAD TO RETRIEVE THE WIRE + BALLOON. ANOTHER WIRE WAS TAKING AND ADVANCING THE BALLOON OVER A NEW SAFARI WIRE WENT OKAY. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: A NEW SAFARI WIRE + A NEW ZMED BALLOON WHAT IS THE NEXT COURSE OF ACTION?: NA. 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: DESCRIBE ANATOMY (BICUSPID, TRICUSPID, GOTHIC ARCH, ACUTE BEND, HORIZONAL AORTA, DEGREE OF CURVATURE ETC)? ANSWER: TRICUSPID. QUESTION: PLEASE SPECIFY THE DEVICE MALFUNCTION - WHEN DID IT OCCUR, HOW WAS IT OBSERVED, HOW WAS THE ISSUE RESOLVED, HOW WAS THE PROCEDURE COMPLETED, DID ANY PATIENT HARM OCCUR (IF YES, ARE ANY PATIENT STATUS UPDATES AVAILABLE)? ANSWER: ISSUE RESOLVED BY TAKING A NEW SAFARI + BALLOON ZMED DIAM 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21711504 ↗
• MalfunctionDec 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING THE PROCEDURE THE SAFARI GUIDE IS STUCK IN THE GUIDE PASS AFTER SEVERAL ATTEMPTS WE REMOVED THE GUIDE IN THE CONDITION AS IN THE PHOTO. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE (SAME MODEL). NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885251 ↗
• MalfunctionOct 14, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: SMALL SAFARI WIRE WAS CORRECTLY POSITIONED IN THE LEFT VENTRICLE, WHEN PUSHING THE ACCURATE NEO 2 DELIVERY SYSTEM OVER THE WIRE EVERYTHING WAS GOING WELL UNTIL WE CAME UP WITH THE DELIVERY SYSTEM AT THE LEVEL OF THE ASCENDING AORTA. SUDDENLY, THE PATIENT COMPLAINED ABOUT MORE PAIN AND WE NOTICED THAT THERE WAS MORE WIRE IN THE VENTRICLE THAN DESIRED. WE'VE WITHDRAWN THE DELIVERY SYSTEM AND ALSO THE WIRE A LITTLE BIT. WE WAITED A WHILE FOR THE PATIENT TO RECOVER. WITH A LOT OF TRACTION ON THE WIRE, IT WAS VERY DIFFICULT FOR US TO GET THE DELIVERY SYSTEM ON SITE. COMMISSURE ALIGNMENT WAS POSSIBLE (WHEN YOU RUN THE SYSTEM, THEN THE WIRE ALSO ROTATED). THE VALVE WAS DEPLOYED AND IS NICELY PLACED. HOWEVER, IT WAS NOT POSSIBLE TO WITHDRAW THE SAFARI WIRE FROM THE DELIVERY SYSTEM AND WE HAD TO REMOVE EVERYTHING TOGETHER. THE CURL OF THE SAFARI WIRE GOT STUCK ON THE STABILISATION ARCH, WE STRUGGLED TO REMOVE IT. FORTUNATELY, NO DISLOCATION OF THE VALVE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: STAYING CALM AND STAYING CALM AND SEE WHAT WAS POSSIBLE STEP BY STEP. DISCUSSION WAS MADE TO INSERT THE POST DILATION BALLOON VIA CONTRALATER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438535 ↗
• MalfunctionJul 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE SAFARI WAS UNPACKAGED AND DELIVERED TO THE PHYSICIAN. WHEN HE TRIED TO ADVANCE THE INSERTOR, HE REALIZES THAT THE COILS OF THE WIRE WERE ENTANGLED AND BENT. THE DEFECTIVE WIRE WAS DISCHARGED, AND THE PROCEDURE CONTINUED WITH A NEW WIRE. THE ISSUE OCCURED DURING PREPARATION/PRIOR TO THE PROCEDURE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NO TROUBLESHOOTING STEPS. WHAT IS THE NEXT COURSE OF ACTION?: COLLECT THE WIRE AND TAKE IT TO BE ANALYZED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. QUESTION: WAS THERE A DEVICE INTERACTION WITH ANOTHER DEVICE? IF YES, PLEASE EXPLAIN AND PROVIDE OTHER PRODUCT DETAILS: ANSWER: NO. QUESTION: ARE ANY PATIENT STATUS UPDATES AVAILABLE? ANSWER: PATIENT ALIVE AND DOING WELL. QUESTION: IS IT KNOWN WHAT CAUSED THE DEVICE DAMAGE? ANSWER: NO. QUESTION: WHAT WERE POSSIBLE CONTRIBUTING FACTORS (COMORBIDITIES, ANATOMY CHARACTERISTICS, ETC)? ANSWER: ISSUE UNRELATED TO PATIENT. QUESTION: WHEN SPECIFICALLY DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: AFTER OPENING THE PACKAGE. QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691602 ↗
• MalfunctionJun 20, 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 GUIDE-WIRE INTO THE CATHETER, THEY WERE UNABLE TO ADVANCE THE GUIDE-WIRE INTO THE CATHETER THROUGH THE J-STRAIGHTENER. THE GUIDEWIRE WAS TRAPPED THE GUIDEWIRE WENT NOT INTO THE PATIENT, JUST THE J-STRAIGHTENER TOUCHED THE PIGTAIL AND THAT'S WHY SOME BLOOD IS INTO THE STRAIGHTENER. 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: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578355 ↗
• MalfunctionMay 28, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED ON JUNE 21, 2024: A REVIEW OF THE PROVIDED MEDIA WAS CONDUCTED. THERE ARE 15 SERIES OF ANGIOGRAPHIC MEDIA. CONTRAST SHOWS 3-CUSP VIEW. INITIAL POSITIONING, STEP 1A (UPPER CROWNS RELEASED) AND STEP 1B (STABILIZATION ARCHES RELEASED) ARE SHOWN. THE VALVE IS FULLY DEPLOYED AND APPEARS TO BE HIGH RELATIVE TO, ALTHOUGH STILL IN CONTACT WITH, THE NATIVE ANNULUS. THE VIEW IS CHANGED AND THE VALVE HAS EMBOLIZED INTO THE ASCENDING AORTA. A SECOND ACURATE VALVE IS SHOWN INITIAL POSITIONING, STEP 1A, AND STEP 1B. CONTRAST SHOWS THE POSITION OF THE VALVE AFTER STEPS 1A AND 1B ARE COMPLETED. THE SECOND VALVE IS FULLY DEPLOYED AND CONTRAST SHOWS LITTLE TO NO LEAK THROUGH THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19409101 ↗
• MalfunctionApr 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: AUTONOMOUS PROCEDURE, PHYSICIAN REPORTS TO US: GUIDEWIRE DAMAGED AT TIP BEFORE USE. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DID THE END USER ATTEMPT TO REMOVE THE GUIDEWIRE FROM THE HOOP PRIOR TO NOTICING THE DAMAGE? THE DAMAGE WAS NOTICED BEFORE TOUCHING THE GUIDEWIRE, JUST AFTER OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191879 ↗
• MalfunctionApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: THE PATIENT WAS SUITABLE FOR ACURATE NEO2 SIZE M. FIRST VALVE SMM470181 WAS IMPLANTED A BIT HIGHER, BUT DUE TO PVL PHYSICIANS DECIDED TO DO POST-DILATATION. AFTER GOOD POST-DILATATION PHYSICIANS REMOVED SAFARI WIRE WITHOUT PIGTAIL. FIRST VALVE WAS MOVED HIGHER PROBABLY DUE TO SAFARI TOUCHED THE STABILIZATION ARCH. PATIENT CONDITION WAS STABLE, THERE WAS GOOD BLOOD FLOW TO BOTH CORONARIES, BUT PATIENT HAD STILL PARAVALVULAR LEAK, PHYSICIANS DECIDED TO IMPLANT SECOND VALVE OF SAME SIZE. SECOND VALVE WAS IMPLANTED GOOD (TAVI IN TAVI). WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT WAS THE PROBLEM ASSOCIATED WITH LABELED USE? YES ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION. EVENT RESOLVED? YES PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE: RELATED DID PATIENT HAVE MYOCARDIAL INFARCTION <72 HOURS PRIOR TO PROCEDURE? NO WAS THE AORTIC ANNULUS CALCIFIED? NO WAS THERE PRIOR BRACHYTHERAPY OF THE TARGET AREA? NO WHAT WAS THE VASCULAR ACCESS SITE? FEMORAL & RIGHT WAS THE ILIOFEMORAL SEVERELY TORTUOUS? MILD & MODERATE WAS THE ILIOFEMORAL SEVERELY CALCIFIED? MILD WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014213 ↗
• MalfunctionFeb 20, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT: DURING THE PROCEDURE THE BODY AND THE END OF THE GUIDE WERE PEELED. CONSEQUENCE: NEED TO REMOVE THE GUIDE TOGETHER WITH THE RELEASE SYSTEM (EVOLUT PRO+). NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740250 ↗
• MalfunctionFeb 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: VIA EP PER: DESCRIPTION OF THE INCIDENT: THE GUIDEWIRE IS PEELED BEFORE BEING TAKEN OUT OF PACKAGING. NUMBER OF PATIENTS OR PERSONS CONCERNED: 1 NUMBER OF DEVICES CONCERNED: 1 IS THIS TYPE OF INCIDENT PROVIDED FOR IN THE PACKAGE LEAFLET? OF USE OF THE MANUFACTURER? NO CLINICAL CONSEQUENCES AND CURRENT PATIENT OR PERSON INVOLVED OUTCOME: NONE. ACTIONS TAKEN FOR THE PATIENT REGARDING THE MD: NEW MD USED WITHOUT PROBLEMS. VIA REP'S EMAIL: - CONTEXT : ISSUE BEFORE INSERTING THE DEVICE INTO THE PATIENT - NOTES: THE SAFARI WAS DAMAGED (FRAYED) WHEN TAKEN OUT OF THE PACKAGING RESPONSES TO QUESTIONS RECEIVED ON 31 AUGUST 2023: 1. IS THERE A CLOSE UP IMAGE OF THE REPORTED DAMAGE? NO PHOTO OR IMAGE. 2. DID THE ISSUE OCCUR DURING REMOVAL OF THE SAFARI2 GUIDEWIRE FROM THE DISPENSER HOOP? YES, DURING REMOVAL FROM THE DISPENSER HOOP. 3. THE NARRATIVE INDICATES THAT A NEW MD WAS USED. WAS THE REPLACEMENT MD ANOTHER SAFARI2 DEVICE (SAME MODEL OR DIFFERENT MODEL OR NON BSC PRODUCT)? SAME PRODUCT SAFARI 2 4. WHAT TYPE OF PROCEDURE WAS THIS FOR? TAVI 5. WHAT WAS THE ALTERNATIVE METHOD FOR COMPLETION OF THE PROCEDURE? CHANGE THE DEVICE 6. THERE WAS NO PATIENT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738930 ↗
• DeathJan 9, 2024Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  EVENT DESCRIPTION: GOOD INITIAL POSITION, BASED ON REPORT AND CHECKED. INITIAL TROUBLE TRYING TO PROPERLY ACCOMMODATE SAFARI GUIDEWIRE, INTERFERING WITH MITRAL APPARATUS. SUGGESTED TO CHANGE FOR AN EXTRA SMALL SAFARI AS IT SEEMED TO BE A SHORT VENTRICLE, BUT PHYSICIANS REFUSED TO DO IT. EFFECTIVE PREDILATION DONE WITH 20MM BALLOON. VALVE MARKER POSITIONED AT ANNULUS LEVEL, BUT DUE TO HORIZONTAL AORTA REMAINED CENTRALIZED AND IN AN UNSTABLE POSITION. GUIDEWIRE TENDING TO GO AORTIC, SO PHYSICIAN WAS CONSTANTLY CORRECTING DEPTH AND VALVE POSITION. UPPER CROWN OPENED AND CHECKED THERE WAS NO PARALLAX. VALVE AND GUIDEWIRE WAS REPOSITIONED BASED ON UPPER CROWN TO NATIVE VALVE POSITION AND FULLY OPEN KNOB 1 TO DEPLOY STABILIZATION ARCHES. NO PARALLAX. AS POSITION WAS NOT STABLE, USE OF PACEMAKER FOR FINAL DEPLOYMENT WAS CONSIDERED. NEW ADJUSTMENT OF VALVE POSITION AND GUIDEWIRE WAS PERFORMED AND DEPLOYED VALVE WITH PACEMAKER AT 120BPM. VALVE WAS PUSHED UP AND ENDED HANGING AT THE EDGE OF THE AORTIC ANNULUS. AORTOGRAM REVEALED SEVERE INSUFFICIENCY. DONE POSTDILATION AND VALVE POPPED UP. WHILE PHYSICIANS SNARED THE VALVE, A NEW VALVE WAS LOADED IN A NEW DS, AND IMPLANTED IN THE CORRECT POSI

  Patient problems: Cardiac Perforation

  MAUDE report 18476162 ↗
• MalfunctionJan 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: SAFARI WIRE WOULD NOT PASS THROUGH THE INTRODUCER SLEEVE WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ANOTHER WIRE TAKEN WHAT IS THE NEXT COURSE OF ACTION?: SAME. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PROCEDURE DATE-UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465144 ↗
• MalfunctionDec 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS MEDWATCH REPORT PERTAINS TO THE SECOND OF TWO GUIDEWIRES IN THE REPORTED EVENT. MEDWATCH REPORT 2126666-2023-00083 CAPTURES THE FIRST GUIDEWIRE. EVENT DESCRIPTION: AT THE TIME OF THE EVENT, THE VALVE WAS CROSSED AND A PIGTAIL WAS IN THE LEFT VENTRICLE. THEN, A SAFARI WIRE NEEDS TO BE INSERTED IN THE 6FRENCH PIGTAIL TO BE PLACED IN THE LEFT VENTRICLE IN ORDER TO BRING THE DELIVERY SYSTEM. AT THIS STEP, THE SAFARI SMALL WIRE COULD NOT BE INSERTED IN THE PIGTAIL HUB. THE J-STRAIGHTENER OF THE SAFARI WAS USED AS USUAL TO INSERT THE SAFARI IN THE PIGTAIL HUB. THE SAFARI COULD NOT BE ADVANCED IN THE PIGTAIL AND WAS STUCK IN THE PIGTAIL HUB. BY TRYING TO ADVANCE THE SAFARI WIRE, THE SAFARI WIRE WAS DAMAGED AND THE WIRE CURVE UNCOILED. ANOTHER SAFARI SMALL WIRE WAS USED FOR WHICH THE SAME PROBLEM OCCURRED. THIS SAFARI WIRE COULD NOT BE ADVANCED EITHER. THIS SAFARI SMALL WIRE WAS DAMAGED AND THE CURVE UNCOILED. AFTER FAILED ATTEMPTS AT INSERTING BOTH WIRES, AN EXTRASMALL SAFARI WIRE WAS USED WHICH WAS SUCCESSFULLY INSERTED IN THE PIGTAIL HUB AND THE PROCEDURE COULD CONTINUE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ANOTHER SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365658 ↗
• MalfunctionDec 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS MEDWATCH REPORT PERTAINS TO THE FIRST OF TWO GUIDEWIRES IN THE REPORTED EVENT. MEDWATCH REPORT 2126666-2023-00084 CAPTURES THE SECOND GUIDEWIRE. EVENT DESCRIPTION: AT THE TIME OF THE EVENT, THE VALVE WAS CROSSED AND A PIGTAIL WAS IN THE LEFT VENTRICLE. THEN, A SAFARI WIRE NEEDS TO BE INSERTED IN THE 6FRENCH PIGTAIL TO BE PLACED IN THE LEFT VENTRICLE IN ORDER TO BRING THE DELIVERY SYSTEM. AT THIS STEP, THE SAFARI SMALL WIRE COULD NOT BE INSERTED IN THE PIGTAIL HUB. THE J-STRAIGHTENER OF THE SAFARI WAS USED AS USUAL TO INSERT THE SAFARI IN THE PIGTAIL HUB. THE SAFARI COULD NOT BE ADVANCED IN THE PIGTAIL AND WAS STUCK IN THE PIGTAIL HUB. BY TRYING TO ADVANCE THE SAFARI WIRE, THE SAFARI WIRE WAS DAMAGED AND THE WIRE CURVE UNCOILED. ANOTHER SAFARI SMALL WIRE WAS USED FOR WHICH THE SAME PROBLEM OCCURRED. THIS SAFARI WIRE COULD NOT BE ADVANCED EITHER. THIS SAFARI SMALL WIRE WAS DAMAGED AND THE CURVE UNCOILED. AFTER FAILED ATTEMPTS AT INSERTING BOTH WIRES, AN EXTRASMALL SAFARI WIRE WAS USED WHICH WAS SUCCESSFULLY INSERTED IN THE PIGTAIL HUB AND THE PROCEDURE COULD CONTINUE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ANOTHER SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365515 ↗
• MalfunctionDec 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: STRAIGHTFORWARD PROCEDURE. EFFECTIVE PREDILATION WITH A 24MM BALLOON. HORIZONTAL AORTA. FAST PACING DURING DEPLOYMENT. STRAIGHTFORWARD DEPLOYMENT AND GOOD POSITIONING OF THE VALVE. AFTER REMOVAL OF THE DS, THE VALVE FRAME WAS UNDEREXPANDED AND THEY WANTED TO POSTDILATE. THEY WANTED TO PUT THE SAFARI SMALL WIRE BACK INTO THE CORDIS 6FR PIGTAIL TO BRING THE POSTDILATION BALLOON. THE J-STRAIGHTENER OF THE SAFARI WAS USED AS USUAL TO INSERT THE SAFARI IN THE PIGTAIL HUB. THE SAFARI COULD NOT BE ADVANCED IN THE PIGTAIL AND WAS STUCK. THE PHYSICIAN MENTIONED THAT THE SAFARI WIRE MUST HAVE BEEN STUCK IN THE SPACE LEFT IN BETWEEN THE J-STRAIGHTENER TIP AND THE INNER PART OF THE PIGTAIL HUB. TRYING TO ADVANCE THE SAFARI IN THE PIGTAIL HUB, THE CURVE OF THE SAFARI RESULTED TO BE DAMAGED (BENT). THE SMALL SAFARI WIRE WAS REPLACED BY A NEW ONE WITH THE SAME LOT NUMBER. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: AFTER TRYING TO ADVANCE THE SAFARI WIRE WITHOUT SUCCESS INTO THE PIGTAIL HUB, THEY REPLACED THE SAFARI SMALL FOR ANOTHER SAFARI SMALL. WHAT IS THE NEXT COURSE OF ACTION?: A NEW SAFARI WIRE SMALL WAS USED AND THE POSTDILATION BALLOON COULD BE BROUGHT AT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364997 ↗
• MalfunctionNov 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS MEDWATCH REPORT PERTAINS TO THE FIRST OF TWO GUIDEWIRES IN THE REPORTED EVENT. MEDWATCH REPORT 2126666-2023-00076 CAPTURES THE SECOND GUIDEWIRE. EVENT DESCRIPTION: CUSTOMER TRIED TO USE THE SAFARI WIRE FOR AN IMPLANTATION WITH A DIFFERENT VALVE. THEY COULDN'T REMOVE THE WIRE FROM THE PLASTIC SLEEVE. WIRE WAS DAMAGED AND THEY USED ANOTHER ONE. SAME SITUATION BY THE NEXT ONE. THIRD SAFARI WIRE COULD BE USED SUCCESSFULLY. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ANOTHER SAFARI WIRE WAS USED PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE DATE-UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048719 ↗
• MalfunctionOct 31, 2023Entrapment of Device; Material Split, Cut or Torn; Entrapment of Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE WIRE WAS STUCK INTO THE LUMEN OF EVOLUT PRO+ CATHETER; THEY WERE NOT ABLE TO PUSH OR PULL IT. THEY REMOVED ALL THE SYSTEM, AND THE WIRE WAS "DECONSTRUCTED", THE WIRE COILS ARE "UNRAVELED". WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NONE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED 10-30-2023: QUESTION: LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. ANSWER: UNKNOWN. QUESTION: IS THIS A NEW OR EXPERIENCED USER? ANSWER: EXPERIENCED USER. QUESTION: WHAT DOES THE END USER BELIEVE CAUSED THE WIRE TO STICK IN THE LUMEN OF THE EVOLUT PRO+ CATHETER? ANSWER: HE DOESN'T KNOW. QUESTION: HOW WERE THE DEVICES REMOVED FROM THE PATIENT? ANSWER: THE DOCTOR HAD A LOT OF DIFFICULTY AND HAD TO PULL VERY HARD TO FINALLY GET IT OUT WITH THE CATHETER FROM THE VALVE. QUESTION: WHAT DOES THE END USER BELIEVE CAUSED THE WIRE TO [?]UNRAVEL' AS REPORTED? ANSWER: HE DOESN'T KNOW. QUESTION: WAS THERE RESISTANCE FELT ANYTIME DURING INSERTION, ADVANCEMENT, OR WITHDRAWAL? ANSWER: NO. QUESTION: WAS THE VALVE SUCCESSFULLY IMPLANTED? ANSWER: YES. P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039754 ↗
• InjuryAug 28, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 07SEPT2023: QUESTION: LISTING AND MODEL OF THE AL2 DEVICE? ANSWER: N/A, THE COMPLAINANT DID NOT HAVE THE INFORMATION. QUESTION: THE INFORMATION STATES, REVIEWING THE CASE WITH THE PROCTOR'. PLEASE CONFIRM WAS THIS A NEW OR EXPERIENCED USER? ANSWER: THE USER IS EXPERIENCED IN TAVI IMPLANTATION, BUT NOT IN THE USE OF ACURATE, BEING HIS SECOND CASE. QUESTION: WHAT METHOD WAS USED TO DETERMINE THAT THE PERFORATION WAS CAUSED BY THE SAFARI2 GUIDEWIRE? WAS THERE MEDIA REVIEWED, ETC.? ANSWER: ANGIOGRAPHY SHOWED THE ADVANCEMENT OF THE SAFARI, AFTER THAT, A TRANSTHORACIC ECHO WAS REQUESTED TO VERIFY IT. THE IMAGES WERE ATTACHED. QUESTION: WAS THE PERICARDIAL EFFUSION NOTICED PRIOR TO INSERTION OF THE BAV DEVICE OR AFTER THE BALLOON WAS ALREADY IN POSITION? ANSWER: IT WAS NOTICED PRIOR TO INSERTION OF THE BAV QUESTION: PLEASE PROVIDE THE TYPE OF BALLOON CATHETER USED IN THE PROCEDURE TO PERFORM THE BAV. INCLUDE DETAILS ON THE TYPE OF BALLOON CATHETER, BRAND NAME, SIZES, ETC. ANSWER: A 20X40 BALLON WAS USED, I DO NOT HAVE FURTHER DETAILS ABOUT IT. QUESTION: WAS BAV SUCCESSFULLY COMPLETED OVER THE SAFARI2 WIRE? ANSWER: YES. QUESTION: WAS

  Patient problems: Cardiac Arrest; Cardiac Perforation; Pericardial Effusion

  MAUDE report 17632800 ↗
• MalfunctionAug 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: SAFARI 2 SM GUIDEWIRE USED DURING PICARDIA SHORT CUT PROCEDURE, FOLLOWED BY AN EDW THV DELIVERY. UPON REMOVAL OF THE TAVR DELIVERY SYSTEM, THE WIRE CAME BACK ACROSS THE VALVE WITH THE DEVICE. PER THE PHYSICIAN, HE PULLED EVERYTHING OUT AT ONCE. HE ADMITTED THAT HE DID NOT PULL THE SAFARI WIRE INSIDE OF A CATHETER BEFORE PULLING BACK ACROSS THE VALVE AND OUT OF THE BODY. 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?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION: QUESTION: WHEN SPECIFICALLY DURING DEVICE PREP OR DURING THE PROCEDURE DID THE DEVICE DAMAGE OCCUR? ANSWER: NOTICED AT THE END OF THE PROCEDURE AFTER REMOVAL QUESTION: WHERE SPECIFICALLY ON THE DEVICE DID THE DAMAGE OCCUR? ANSWER: TAPERED END QUESTION: WAS THE ORIGINAL SAFARI2 GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE? ANSWER: SAME SAFARI 2 GUIDEWIRE WAS USED THE ENTIRE CASE. DAMAGE OCCURRED UPON REMOVAL OF THE WIRE AT THE END OF THE CASE. QUESTION: PLEASE DESCRIBE WHAT DEVICE DAMAGE OCCURRED AND WHERE ON THE DEVICE THE DAMAGE WAS LOCATED. ANSW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557378 ↗
• DeathAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: THE EVENT HAPPENED DURING THE PROCEDURE. ISLEEVE INTRODUCER SHEATH, SAFARI WIRE AND SENTINEL DEVICE WAS USED INTO THE PATIENT. DELIVERY SYSTEM, LOADING KIT AS WELL AS VALVE (SIZE S) WAS OPENED AND VALVE HAS BEEN LOADED. BALLOON FOR PRE-DILATATION AND LOADED VALVE WAS NOT USED INTO THE PATIENT. AFTER SAFARI WIRE INSERTION INTO THE LEFT VENTRICLE THE PATIENT'S BLOOD PRESSURE HAS SUDDENLY DROPPED TO A 50/40. IMMEDIATE ECHOCARDIOGRAPHY WAS UNDERTAKEN. ECHO ANALYSIS SHOWED NO PERICARDIAL EFFUSION. THE BLOOD PRESSURE DROPPED MUCH MORE. REANIMATION HAS UNDERTAKEN: HEART MASSAGE BY THE PHYSICIANS. THE PATIENT WAS GIVEN ADRENALINE. THE DOCTORS CHECKED THE CORONARY ARTERIES BLOOD FLOW BY PROCEEDING CORONAROGRAPHY AND REALIZED LEFT CORONARY ARTERY (LCA) AND LEFT CORONARY DESCENDING (LAD) WAS OCCLUDED. THE PHYSICIANS UNDERTOOK THE PERCUTANEOUS CORONARY INTERVENTIONS IN THE CORONARIES: CORONARY ANGIOPLASTY AND STENTING. DURING ATTEMPTS TO SAVE THE PATIENT'S LIFE, THE PATIENT HAS HAD VENTRICULAR FIBRILLATION - DEFIBRILLATION WAS UNDERTAKEN. UNFORTUNATELY, DESPITE UNBLOCKING THE LCA, PROBABLY BECAUSE OF TOO LONG MYOCARDIAL HYPOXIA, THE ATTEMPTS TO SAVE THE PATIENT FAILED AND

  Patient problems: Cardiac Arrest; Obstruction/Occlusion

  MAUDE report 17454838 ↗
• MalfunctionJul 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CONSULTANT STATED THE WIRE DID NOT FEEL RIGHT' AND WHEN THE WIRE CAME OUT IT HAD DISINTEGRATED - THE SPIRAL COVER HAD STARTED TO COME OFF . ADDITIONAL INFORMATION PROVIDED 5 JULY 2023: PLEASE REQUEST CONFIRMATION ON WHEN THE ISSUE OCCURRED? WHEN THE WIRE WAS REMOVED FROM THE DISPENSER IT LOOKED FINE. TYPE OF PROCEDURE? TAVI. WHAT IS MEANT BY "AND WHEN THE WIRE CAME OUT IT HAD DISINTEGRATED"? THE WIRE UNCOILED' UPON REMOVING IT FROM THE DELIVERY SYSTEM OF THE VALVE (POST DEPLOYMENT), TIP INTACT BUT UNRAVELLING. THE EXTERNAL COILING WAS THE ONLY THING SUPPORTING THE DISTAL TIP OF THE WIRE. DID THE ISSUE OCCUR DURING REMOVAL OF THE SAFARI2 GUIDEWIRE FROM THE DISPENSER HOOP? THE DAMAGE WAS NOT NOTED ON REMOVAL FROM THE HOOP, AS IT WENT STRAIGHT INTO THE CATHETER (LOOKED INTACT). WAS THERE ANY DAMAGE NOTED TO THE GUIDEWIRE UPON REMOVE FROM THE PACKAGING (PRIOR TO USE)? NO DAMAGE WAS NOTED ON UPON REMOVAL OF THE PACKAGING. HOW WAS THE GUIDEWIRE REMOVED FROM THE DISPENSER HOOP? TAKEN FROM PACKAGING, STOPPER REMOVED, STRAIGHTENER ADVANCED TO DISTAL END OF WIRE, GIVEN TO CONSULTANT. WHERE ON THE WIRE DID IT NOT FEEL RIGHT'? THE WIRE WAS INTACT AT START, UPON USAGE IN THE PATIENT THE CON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333890 ↗