SAFARI2™ H74939706JPNXS0Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00816349012334), received between Sep 2, 2021 and Jun 26, 2026 — classified as 3 deaths, 23 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 26 reports, in the reporter's own words as published by the FDA.

• DeathJun 26, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 25635584 ↗
• DeathJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: WHEN THE SAFARI WAS PRESSED AGAINST A PATIENT WITH A SMALL LEFT VENTRICLE, WIRE PERFORATION OCCURRED. PHYSICIAN COMMENTS: PATIENT OUTCOME: NO PATIENT INJURY. INTRODUCER SHEATH USED: NOT AVAILABLE AT THIS MOMENT. GUIDEWIRE USED: YES - UNKNOWN - SAFARI 2 GUIDE. CATHETER USED: NOT AVAILABLE AT THIS MOMENT. BALLOON CATHETER USED: NOT AVAILABLE AT THIS MOMENT. STENT USED: NONE. INFLATION DEVICE USED: NOT AVAILABLE AT THIS MOMENT. IMAGING CATHETER: UNKNOWN. ADDITIONAL INFORMATION 17JAN2025: QUESTION: PLEASE DESCRIBE THE PATIENT'S CURRENT CONDITION. ANSWER: DECEASED ABOUT 1 MONTH AFTER SURGERY (DUE TO ANOTHER COMPLICATION WHILE RECUPERATING THAT WAS NOT DIRECTLY RELATED TO THIS EVENT). QUESTION: PLEASE PROVIDE DETAILS OF THE CIRCUMSTANCES LEADING UP TO THE PERFORATION. ANSWER: AFTER TAVI VALVE IMPLANTATION, WHEN THE TAVI DEVICE IS REMOVED, THE SAFARI WIRE ADVANCES TOWARD THE APEX OF THE HEART, EXPOSING THE WINDING OF THE TIP OF THE SAFARI WIRE TO THE OUTSIDE OF THE HEART. QUESTION: WHAT IS THE LOCATION OF THE PERFORATION? ANSWER: SEVERAL CENTIMETERS HEADWARD FROM THE APEX OF THE HEART. QUESTION: PLEASE DESCRIBE IN DETAIL WHAT KIND OF PROCEDURE WAS PERFORMED OR PLANNED.

  Patient problems: Cardiac Perforation

  MAUDE report 21244574 ↗
• MalfunctionNov 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT THE INSERTER COULD NOT BE REMOVED, AND THE WIRE WAS DAMAGED WHEN PULLED WITH STRONG FORCE. THE LOCATION OF THE DAMAGE WAS UNKNOWN. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO. RESOLUTION: COMPLETED WITH ANOTHER OF SAME DEVICE. WHERE DID EVENT OCCUR: OUTSIDE THE PATIENT. WHERE DID EVENT OCCUR: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800218 ↗
• MalfunctionApr 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? YES. AT WHAT LOCATION AND WHAT KIND OF DAMAGE WAS OBSERVED? THE LOOP AT THE TIP WAS DAMAGED FROM THE BEGINNING. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027931 ↗
• MalfunctionMar 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: EVENT OTHERS (PLEASE SPECIFY THE DETAILS IN THE EVENT DESCRIPTION COLUMN.) SHAPING: NO SAID THAT THE TIP WAS DEFORMED. PHYSICIAN COMMENTS: PATIENT OUTCOME: NO PATIENT INJURY INFECTED? UNKNOWN TORTUOSITY OF ANATOMY? UNKNOWN PERCENTAGE OF STENOSIS? UNKNOWN LESION CALCIFICATION? UNKNOWN INTRODUCER SHEATH USED: UNKNOWN GUIDEWIRE USED: UNKNOWN GUIDE CATHETER USED: UNKNOWN BALLOON CATHETER USED: UNKNOWN STENT USED: UNKNOWN INFLATION DEVICE USED: UNKNOWN IMAGING CATHETER: UNKNOWN 26 FEBRUARY 2024- DISTRIBUTOR PROVIDED THE FOLLOWING STATEMENT IN RESPONSE TO ATTEMPTS TO GATHER FURTHER EVENT INFORMATION: ACCORDING TO SALES REPRESENTATIVE, IT IS NOT ABLE TO OBTAIN DETAILS ABOUT THIS CASE SINCE ENTRY TO THE HOSPITAL IS CURRENTLY CONTROLLED DUE TO COVID-19. FOR THIS REASON, NO FURTHER INFORMATION IS AVAILABLE. 7 MARCH 2024- RECEIVED NOTIFICATION OF PRODUCT RETURN ALONG WITH IMAGES. BASED ON THE IMAGES, THE EVENT WAS DETERMINED TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920775 ↗
• MalfunctionMar 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING PREPARATION OUTSIDE THE BODY, THE TRANSPARENT INSERT'S COATING WAS TORN AND SEPARATED FROM WIRE, CAUSING IT TO CLOG, AND IT WAS UNABLE TO CROSS. THE DEVICE WAS REPLACED WITH A NEW ONE. PHYSICIAN COMMENTS: THE DEVICE WAS DEFECTIVE. PATIENT OUTCOME: NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886954 ↗
• MalfunctionFeb 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT; THE DEVICE WAS DAMAGED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO AT WHAT LOCATION AND WHAT KIND OF DAMAGE WAS OBSERVED? THE TIP WAS DAMAGED DURING PREPARATION. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778775 ↗
• MalfunctionFeb 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT: DAMAGE HAS OCCURRED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO. AT WHAT POSITION AND WHAT KIND OF DAMAGE WAS OBSERVED? THE WIRE COIL WAS STRETCHED WHEN THE DEVICE WAS PULLED OUTSIDE THE PATIENT DURING INSERTION. TIP PART PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640735 ↗
• MalfunctionJan 26, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: THE DEVICE WAS STUCK WITH INOUE BALLOON. SAFARI WAS NOT STUCK IN PIGTAIL OR OTHER DEVICES UNTIL SAFARI WAS PLACED IN THE LV. AFTER THE SAFARI WAS PLACED IN THE LV, AND THE INOUE BALLOON WAS INSERTED AND ADVANCED TO THE HEAD SIDE OF THE DIAPHRAGM, A THUMP WAS FELT AND COULD NOT ADVANCE THE INOUE BALLOON ANY FURTHER. THE INOUE BALLOON WAS PUSHED BUT IT DID NOT MOVE, AND ON THE OTHER HAND THE INOUE BALLOON WAS ATTEMPTED TO PULL OUT, BUT IT COULD NOT BE PULLED OUT. SAFARI AND INOUE BALLOON WERE REMOVED TOGETHER TO THE OUTSIDE. (NORMALLY, A PIGTAIL IS USED FOR SAFARI INSERTION AND REMOVAL.). THE PROCEDURE WAS COMPLETED USING A NEW BALLOON (SAME MODEL) AND NEW GUIDEWIRE (SAME MODEL). PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588390 ↗
• MalfunctionJan 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: EVENT; THE DEVICE WAS DAMAGED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO. AT WHAT LOCATION AND WHAT KIND OF DAMAGE WAS OBSERVED? IN THE CURVED PART AT THE TIP. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564630 ↗
• MalfunctionJan 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LOOP PART OF THE TIP WAS DEFORMED UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465407 ↗
• MalfunctionNov 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING UNPACKING, THE CORE OF THE WIRE WAS SEEMED TO BE PROTRUDING. 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 18242268 ↗
• MalfunctionOct 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE WIRE COULD NOT BE PULLED OUT OF THE TUBE, AND WHEN PULLED HARD, PART OF THE TIP LIFTED. TIME OF EVENT: PREPARATION. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953070 ↗
• MalfunctionOct 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT: DAMAGE. QUESTION: WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE?; ANSWER: NO. QUESTION: AT WHAT LOCATION AND WHAT KIND OF DAMAGE WAS OBSERVED? ANSWER: IT WAS POINTED OUT THAT THE COIL NEAR THE TIP OF THE GUIDE WIRE HAD STRETCHED. QUESTION: PATIENT OUTCOME? ANSWER: NO PATIENT INJURY. QUESTION: WAS THE SAFARI USED IN A PATIENT? ANSWER: NO THE ISSUE OCCURRED OUTSIDE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905622 ↗
• MalfunctionSep 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN THE DEVICE WAS ATTEMPTED TO BE REMOVED FROM THE HOOP, THE RESISTANCE WAS SEVERE, AND WHEN ATTEMPTING TO REMOVE WITH A LITTLE FORCE, THE DEVICE GOT KINKED; THEREFORE, THE DEVICE'S USE WAS DISCONTINUED. PHYSICIAN COMMENTS: PATIENT OUTCOME: NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (SAME MODEL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17747139 ↗
• MalfunctionSep 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN THE PRODUCT WAS OPENED DURING PREPARATION, THE SPRING WIRE WAS STRETCHED. PHYSICIAN COMMENTS: PATIENT OUTCOME: NO PATIENT INJURY THE ISSUE WAS DISCOVERED WHEN THE PRODUCT WAS OPENED DURING PREPARATION OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (SAME MODEL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745565 ↗
• MalfunctionAug 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT: THE TIP OF THE WIRE GOT STRETCHED WHEN IT WAS REMOVED FROM THE PROTECTIVE SHEATH; THEREFORE, THE DEVICE WAS NOT USED. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490768 ↗
• MalfunctionAug 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT; THE DEVICE WAS DAMAGED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE?YES AT WHAT LOCATION AND WHAT KIND OF DAMAGE WAS OBSERVED? THE OUTER COIL OF THE TIP LOOP WAS STRETCHED. PATIENT OUTCOME: NO PATIENT INJURY THE DAMAGED OCCURED PRIOR TO USE. THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452204 ↗
• MalfunctionJun 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT: DAMAGE HAS OCCURRED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO. AT WHAT POSITION AND WHAT KIND OF DAMAGE WAS OBSERVED? THE COILED PART AT THE TIP OF THE WIRE WAS UNRAVELED. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191760 ↗
• MalfunctionJan 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DIFFERENT WIRES USED IN THE PROCEDURE. MEDWATCH REPORT MDR 2126666-2023-00007 CAPTURES THE FIRST DEVICE. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: STUCK IN CATHETER AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. SEVERITY OF TORTUOUS? SEVERE % OF STENOSIS? 75 CALCIFICATION SEVERITY: MILD INTRODUCER SHEATH USED: NONE GUIDEWIRE USED: NONE GUIDE CATHETER USED: NONE BALLOON CATHETER USED: NONE STENT USED: NONE INFLATION DEVICE USED: NONE IMAGING CATHETER: NONE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON JANUARY 6, 2023: THE INFORMATION IN THE REPORT INDICATES STUCK IN CATHETER; HOWEVER, THERE IS NO MENTION OF HOW THE DEVICES WERE REMOVED AND IF BOTH THE WIRE AND CATHETER HAD TO BE EXCHANGED. A. PLEASE CLARIFY DID THE SAFARI2 GUIDEWIRE AND CATHETER HAVE TO BE REMOVED FROM THE PATIENT AS ONE DEVICE OR WAS THERE DIFFICULTY ADVANCING THE WIRE THROUGH THE CATHETER AND THEREFORE ONLY AN EXCHANGE OF THE WIRE WITHOUT REMOVING THE CATHETER FROM THE PATIENT? ONLY THIS WIRE WAS REMOVED FROM THE PATIENT WITHOUT REMOVING THE CATHETER FROM THE PATIENT. B. WAS THE ORIGINAL CATHETER USED TO COMPLETE THE PROCEDURE? Y

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273556 ↗
• MalfunctionJan 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DIFFERENT WIRES USED IN THE PROCEDURE. MEDWATCH REPORT MDR 2126666-2023-00008 CAPTURES THE SECOND DEVICE. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: STUCK IN CATHETER AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. SEVERITY OF TORTUOUS? SEVERE % OF STENOSIS? 75 CALCIFICATION SEVERITY: MILD INTRODUCER SHEATH USED: NONE GUIDEWIRE USED: NONE GUIDE CATHETER USED: NONE BALLOON CATHETER USED: NONE STENT USED: NONE INFLATION DEVICE USED: NONE IMAGING CATHETER: NONE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON JANUARY 6, 2023: THE INFORMATION IN THE REPORT INDICATES STUCK IN CATHETER; HOWEVER, THERE IS NO MENTION OF HOW THE DEVICES WERE REMOVED AND IF BOTH THE WIRE AND CATHETER HAD TO BE EXCHANGED. A. PLEASE CLARIFY DID THE SAFARI2 GUIDEWIRE AND CATHETER HAVE TO BE REMOVED FROM THE PATIENT AS ONE DEVICE OR WAS THERE DIFFICULTY ADVANCING THE WIRE THROUGH THE CATHETER AND THEREFORE ONLY AN EXCHANGE OF THE WIRE WITHOUT REMOVING THE CATHETER FROM THE PATIENT? ONLY THIS WIRE WAS REMOVED FROM THE PATIENT WITHOUT REMOVING THE CATHETER FROM THE PATIENT. B. WAS THE ORIGINAL CATHETER USED TO COMPLETE THE PROCEDURE? Y

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273082 ↗
• MalfunctionJan 13, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: THE SAFARI WAS USED IN A BAV CASE. THE INOUE BALLOON WAS THEN ADVANCED, HOWEVER, IT GOT STUCK TOGETHER WITH SAFARI (PRE-DILATION AND DURING DELIVERY). THE INOUE BALLOON GOT STUCK DESPITE PUSHING AND PULLING; THEREFORE, IT WAS REMOVED TOGETHER WITH SAFARI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158156 ↗
• MalfunctionMar 24, 2022Flaked; Flaked

  PER CNF, IT WAS REPORTED THAT: THERE WAS AN ABNORMALITY AT THE SHAPE OF THE TIP, AND A NEW GUIDE WIRE WAS USED. NOTHING IN PARTICULAR. SUPPLEMENTAL INFORMATION PROVIDED: DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED. PROCEDURE COMPLETED. DIFFERENT DEVICE USED (SAME MODEL). SHAPING? NO. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON MARCH 22, 2022: NO PATIENT INFORMATION AS IT OCCURRED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13888857 ↗
• MalfunctionFeb 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT: DAMAGE IS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? YES. PLEASE DESCRIBE IN DETAIL WHERE AND WHAT KIND OF ABNORMALITY WAS FOUND IN THE COMPLAINT CONTENT COLUMN. THERE IS A HIGH POSSIBILITY THAT THE FILM HAD PEELED OFF AND IT COULD NOT BE PROPERLY DONE. WHERE AND WHAT KIND OF DAMAGE WAS OBSERVED; UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548481 ↗
• DeathNov 19, 2021Flaked; Material Integrity Problem; Flaked; Material Integrity Problem

  DAMAGE HAS OCCURRED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO. AT WHAT POSITION AND WHAT KIND OF DAMAGE WAS OBSERVED? THE SHAFT COATING WAS LIFTED AT A POSITION AROUND THE A VALVE WHEN LV WAS INSERTED BEFORE REACHING THE TIP CURVE. ADDITIONAL INFORMATION AND IMAGES RECEIVED ON NOVEMBER 2, 2021: AFTER IMPLANT(RELEASE) SAPIEN, THE PHYSICIAN ATTEMPT TO PERFORM POST-DILATION USING A BALLOON. HOWEVER, THERE WAS RESISTANCE NEAR THE FRONT OF THE VALVE. WHEN THE PHYSICIAN PUSHED THE PRODUCT, THE TIP OF THE WIRE CAUSED A PERFORATION IN THE LEFT VENTRICLE. AFTER THAT, EMERGENCY SURGERY WAS PERFORMED, AND THE PATIENT SURVIVED BUT BECAME BRAIN DEAD. AS A SIDE NOTE, THERE WAS NO WIRE RESISTANCE WHEN ADVANCING SAPIEN. IN ADDITION, THERE WAS NO RESISTANCE WHEN REMOVING.

  Patient problems: Cardiac Perforation

  MAUDE report 12843831 ↗