SAVION FLX™ H7493942230010Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729978817), received between Sep 17, 2018 and Sep 30, 2024 — classified as 26 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, REQUIRING SNARE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED TIBIAL VESSELS. A SAVION FLX GUIDEWIRE WAS SELECTED FOR RIGHT LOWER EXTREMITY ARTERIOGRAM. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CROSS THE TORTUOUS ANATOMY AT THE PATIENT'S DORSALIS PEDIS OR LOOP ARTERY. HOWEVER, WHILE CROSSING THE WIRE THROUGH THE ARTERY, THE DISTAL END OF THE GUIDEWIRE TIP BROKE OFF AND DETACHED FROM THE REMAINING WIRE END. THE PHYSICIAN HAD TO USE A SNARE DEVICE TO CAPTURE THE BROKEN TIP OF THE WIRE AND REMOVE IT FROM THE PATIENT'S ARTERY. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE CORRECT DEVICE USED IN THE PROCEDURE WAS V-14 CONTROL WIRE. THE SAVION FLX GUIDEWIRE WAS NOT USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334638 ↗
• InjuryMay 10, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINED INSIDE THE PATIENT. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED MID ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON CROSSING THE LESION, THERE WAS RESISTANCE, AND WIRE BECAME STUCK. CONSEQUENTLY, IT WAS NOTED THAT THE TIP BROKE OFF IN SUBINTIMAL PLANE. THE GUIDEWIRE WAS REMOVED FRACTURED. THERE WERE ATTEMPTS TO REMOVE THE DETACHED TIP BY FLUSHING, HOWEVER, IT WAS DECIDED TO LEAVE IT INSIDE THE PATIENT AS IT WAS NON FLOW LIMITING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19286621 ↗
• InjurySep 12, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE, REQUIRING ADDITIONAL INTERVENTION. THIS SAVION FLX GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE OF THE CRURAL ARTERIES BELOW THE KNEE. THIS GUIDEWIRE HAD A SMOOTH PASSAGE TO THE 20% STENOSED, MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY WITH NO DIFFICULTIES OBTAINING THE CORRECT POSITIONING OF THE GUIDEWIRE. THEN PTA WAS SUCCESSFULLY PERFORMED WITH A NON-BOSTON SCIENTIFIC BALLOON OVER THIS GUIDEWIRE. THE BALLOON WAS REMOVED AND WAS REPLACED WITH A LARGER BALLOON; HOWEVER, WHEN ADVANCING THE LARGER BALLOON, RESISTANCE WAS FELT, AND IT WAS NOTED THE NON-BOSTON SCIENTIFIC CATHETER WAS NOT AT THE SAME LOCATION AS THE GUIDEWIRE. IT WAS THEN VISUALIZED THAT THE GUIDEWIRE WAS BROKEN APPROXIMATELY 30CM FROM THE TIP. THE PIECE OF GUIDEWIRE WAS REMOVED VIA SNARING AND THE PROCEDURE WAS COMPLETED USING A NEW GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728495 ↗
• InjuryFeb 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. A SAVION FLX GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, THE TIP OF THE GUIDEWIRE BECAME DISCONNECTED AND WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16389963 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A SAVION FLX GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, WHEN PLACING THE CATHETER OVER THE WIRE, THE WIRE COATING WAS PEELED. THE DEVICE WAS REMOVED INTACT AND ANOTHER SAVION GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584825 ↗
• InjuryJun 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DETACHED GUIDEWIRE TIP COULD NOT BE RETRIEVED. A SAVION FLX WAS SELECTED FOR USE. THE GUIDEWIRE WAS ADVANCED INTO THE LOWER LEG AND INTO STENOSED AND CALCIFIED ANTERIOR TIBIAL ARTERY. THE CHANNEL WAS NARROW BUT THE GUIDEWIRE WAS PLACED. HOWEVER, THE PHYSICIAN OBSERVED THAT THE DISTAL TIP HAD DETACHED. A SNARE WAS UNSUCCESSFUL IN REMOVING THE TIP. THERE WERE NO PATIENT COMPLICATIONS AND NO FURTHER INTERVENTION IS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14681763 ↗
• InjuryFeb 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PEDAL ARTERY (PA). A SAVION FLX GUIDEWIRE WAS ADVANCED TO GAIN ACCESS FROM THE FOOT UP TO THE PERONEAL ARTERY. HOWEVER, DURING THE PROCEDURE, A BIT OF RESISTANCE WAS FELT UPON ATTEMPTING TO ADVANCE THE DEVICE AND THE ENTIRE FLOPPY TIP OF THE GUIDEWIRE BROKE OFF IN PA AND WAS LEFT BEHIND. THE WIRE WAS REMOVED BUT THE TIP OF THE GUIDEWIRE HAD TO BE LEFT IN THE PATIENT'S FOOT DUE TO THE SIZE OF THE VESSEL AND NO DEVICE OR SNARE SMALL ENOUGH TO ATTEMPT A RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVION GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13586585 ↗
• InjurySep 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS PROXIMAL ANTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE TIP OF WIRE CAME OFF INSIDE THE PATIENT BODY. THE LESION WAS ALREADY OCCLUDED SO THE PHYSICIAN DECIDED JUST TO LEAVE IT AND TREAT THE PERONEAL ARTERY. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS FINE AND FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12553836 ↗
• InjuryJul 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CHRONIC CRITICAL LIMB ISCHEMIA (CLI). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PEDAL VESSELS. A 300 CM SAVION FLX GUIDEWIRE WAS INSERTED TO THE LESION. HOWEVER, THE GUIDEWIRE TIP CURLED UP IN THE OCCLUDED SEGMENT AND IT WAS NOTICED THAT THE TIP BROKE OFF. COYOTE BALLOON WAS BEING USED AS A CATHETER. THE WIRE WAS REMOVED BUT THE TIP WAS LEFT IN A VERY SMALL OCCLUDED SEGMENT. THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12197184 ↗
• InjuryJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL POSTERIOR TIBIAL ARTERY (PTA). A SAVION FLX GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE FRACTURED OFF 2-3 CM DISTAL OF THE WIRE. THE DETACHED FRAGMENT WAS LODGED IN THE DISTAL PART OF THE PTA. THE DETACHED PORTION WAS IN TOO SMALL OF A VESSEL AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVION WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12178861 ↗
• InjuryJul 14, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT TIP DETACHMENT REMAINED IN THE PATIENT AND THROMBOSIS OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY (PTA). A SAVION FLX GUIDEWIRE WAS ADVANCED FOR CROSSING THE LESION. HOWEVER, WHEN TRYING TO ADVANCE DOWN THE PTA, THE DISTAL TIP OF THE WIRE WAS BROKEN TO 1-2CM. SUBSEQUENTLY, THROMBUS WAS FORMED AROUND THE WIRE. NO ATTEMPT WAS MADE TO SNARE THE WIRE AS THE AREA WAS OCCLUDED. AN ANTIPLATELET MEDICATION-HEPARIN WAS GIVEN TO THE PATIENT PRIOR TO AND DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC GUIDE WIRE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 12170199 ↗
• MalfunctionMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TIBIAL VESSEL. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. THE GUIDEWIRE WAS REMOVED INTACT FROM THE PATIENT. HOWEVER DURING REINSERTION, THE DISTAL TIP BROKE WHILE THE DEVICE WAS EXTERNAL TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826924 ↗
• InjuryApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE SEPARATION, UNRETRIEVED DEVICE FRAGMENT, AND CANCELED PROCEDURE REQUIRING SURGERY OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL PERONEAL TRUNK. A SAVION FLX GUIDEWIRE WAS ADVANCED; HOWEVER, UPON EXITING THE GUIDE SHEATH, IT WAS NOTICED THAT A FRAGMENT OF WIRE WAS FLOATING IN THE ARTERY. IT WAS DETERMINED UPON FLUOROSCOPY THAT IT WAS THE TIP OF THE WIRE THAT HAD BROKEN OFF. THE WIRE TRAVELED DOWN THE PATIENT'S ARTERY IN THE LEG AND ENDED UP IN THE DISTAL POSTERIOR TIBIAL ARTERY. THE PATIENT IS SCHEDULED TO HAVE THE BROKEN WIRE FRAGMENT REMOVED IN TWO WEEKS.

  Patient problems: Foreign Body In Patient

  MAUDE report 11615072 ↗
• InjuryMar 17, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDE WIRE TIP DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. WHEN A SAVION FLX GUIDEWIRE WAS NAVIGATED TO THE TARGET LESION, THE TIP OF THE WIRE BROKE OFF IN THE PATIENT'S VESSEL AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC WIRE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11500049 ↗
• InjuryFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND UNRETRIEVED DEVICE FRAGMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL POSTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS ADVANCED, HOWEVER; THE TIP BROKE OFF IN THE DISTAL POSTERIOR SIDE BRANCH. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE DETACHED TIP DUE TO THE TIP BEING SMALL. THE PROCEDURE WAS CANCELLED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11259644 ↗
• MalfunctionNov 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED TIBIAL VESSELS. A SAVION FLX GUIDE WIRE WAS ADVANCED TO CROSS THE LESION AND THEN SWITCHED OUT TO TREAT WITH A NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE USING A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE SAVION CROSSED WELL THE FIRST TWO VESSELS. BEFORE PLACING IT BACK INTO PATIENT'S BODY FOR THE THIRD VESSEL, THE PHYSICIAN STRAIGHTENED THE TIP WITH HIS FINGER AND THE TIP OF THE WIRE FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVION WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791896 ↗
• InjuryAug 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE DETACHED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERE CALCIFIED ANTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A PERIPHERAL INTERVENTION. THE GUIDEWIRE WAS INSERTED INTO THE PATIENT WITH A SUBTOTALED ANTERIOR WITH SEVERE CALCIUM, ACCESS WITH A 45CM SHEATH THAT WENT UP AND OVER THE ILIAC TO THE CONTRALATERAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BECAME SEPARATED IN A PART OF THE ANTERIOR VESSEL WHERE THE CALCIUM WAS SEVERE. THE DETACHED TIP OF THE GUIDEWIRE WAS NOT RECOVERED AND WAS LEFT IN THE PATIENT DUE TO THE VESSEL WAS ALREADY A SUBTOTALED AND DID HAVE DISEASE WHERE THERE WAS OCCLUDED. THE PROCEDURE WAS ABANDONED. THE PATIENT WAS IN STABLE CONDITION AND THERE WAS NO NEGATIVE SEQUELAE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10471714 ↗
• InjuryAug 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE WHILE ATTEMPTING TO CROSS SEVERE CALCIFIED LESION OF THE RIGHT COMMON PLANTAR ARTERY OF THE FOOT, THE SAVION WIRE'S TIP DETACHED. GROSS MANIPULATION OF THE WIRE TIP WAS USED WHILE ATTEMPTING TO CROSS LESION. THIS WAS UNSUCCESSFUL AND AS THE WIRE WAS REMOVED THROUGH THE COYOTE BALLOON, THE TIP DETACHED. DUE TO CHRONIC TOTAL OCCLUSION (CTO) OF THAT AREA, THE BROKEN TIP WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION IS OKAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10460327 ↗
• InjuryAug 26, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED. A SAVION FLX WAS SELECTED FOR A PROCEDURE IN THE CALCIFIED DORSALIS PEDIS OF THE LEFT FOOT. THE WIRE WAS ATTEMPTED TO CROSS THROUGH THE CALCIFIED LESION. UPON ATTEMPTING TO WITHDRAW THE WIRE, THE TIP BECAME STUCK IN THE CALCIUM. WHEN THE DEVICE WAS PULLED TO REMOVE FROM THE LESION, THE TIP DETACHED. THE DETACHED TIP WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS ABORTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE ANATOMY WAS MILDLY TORTUOUS, AND THE LESION WAS A 100% CHRONIC TOTAL OCCLUSION WITH SEVERE CALCIFICATION.

  Patient problems: No Code Available

  MAUDE report 10456684 ↗
• InjuryAug 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED INSIDE THE PATIENT, THE DEVICE FRAGMENT WAS NOT RETRIEVED, AND THE PROCEDURE WAS ABORTED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR AN ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION OF THE LEFT COMMON PLANTAR ARTERY. THE TARGET LESION WAS SEVERELY CALCIFIED, AND THE ANATOMY WAS MILDLY TORTUOUS. WHILE BACKING THE GUIDEWIRE OUT OF THE LESION IN AN ATTEMPT TO REDIRECT THE TIP OF THE GUIDEWIRE THROUGH THE LESION AGAIN, THE TIP BECAME STUCK AND EVENTUALLY DETACHED WITHIN THE COMMON PLANTAR ARTERY. THE PROCEDURE WAS ABORTED. NO ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE FRAGMENT, AND NO ADDITIONAL INTERVENTIONS HAVE BEEN SCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION WITH NO CHANGE POST-PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10426124 ↗
• InjuryJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE WIRE BROKE AND WAS LEFT IN THE PATIENT. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE IN A LOWER EXTREMITY INTERVENTION PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE OFF INSIDE OF THE PATIENT AND THE TIP REMAINS IN THE PATIENT'S BODY. NO FURTHER PATIENT COMPLICATIONS OCCURRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10307972 ↗
• InjuryJun 12, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED INSIDE A PATIENT DURING A PROCEDURE. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A PROCEDURE. THE GUIDEWIRE WAS INSERTED THROUGH A 0.018" RUBICON SUPPORT CATHETER. WHILE WORKING ON A POPLITEAL OCCLUSION, THE PHYSICIAN WAS UNABLE TO CROSS THE LESION. WHILE ATTEMPTING TO EXCHANGE THE GUIDEWIRE FOR A DIFFERENT ONE, THE TIP DETACHED INSIDE THE PATIENT IN THE POPLITEAL. THE CASE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10148219 ↗
• InjuryNov 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE DETACHED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE FOR A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION PROCEDURE. DURING THE PROCEDURE, THE DISTAL TIP OF THE GUIDEWIRE BECAME DETACHED AND IT WAS UNABLE TO BE RETRIEVED. THE DETACHED TIP OF THE GUIDEWIRE WAS NOT RECOVERED AND WAS LEFT IN THE PATIENT. THE SFA TREATMENT WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED. ANOTHER ATTEMPT THE RETRIEVE THE WIRE WAS TO BE ATTEMPTED THE FOLLOWING WEEK. IT WAS FURTHER REPORTED THAT THE TIP OF THE GUIDEWIRE BECAME SEPARATED IN A PART OF THE VESSEL THAT DID NOT HAVE DISEASE WHERE THERE WAS NO CALCIFICATION AND VERY MILD TORTUOSITY. PATIENT HAS NOT YET UNDERGONE SURGERY TO REMOVE THE REMAINING FRAGMENT OF GUIDEWIRE AND IT IS UNKNOWN WHETHER FURTHER REMOVAL ATTEMPTS WILL OCCUR. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9369146 ↗
• InjuryAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A PROCEDURE. THE LESION PRESENTED SEVERE CALCIFICATION. DURING THE PROCEDURE, THERE WAS WEAR ON THE GUIDE FROM THE CALCIFICATION AND THE DISTAL TIP OF THE GUIDEWIRE DETACHED. THE DEVICE WAS REMOVED AND THE EVENT WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION REPORTED THAT THE PROCEDURE WAS FOR A TOTAL OCCLUSION USING AN ENDOLUMINAL APPROACH. THE TIP OF THE GUIDEWIRE WAS LEFT INSIDE THE PATIENT. NO MANEUVERS WERE ATTEMPTED TO REMOVE THE GUIDEWIRE TIP. A NON-BSC DEVICE WAS USED TO TREAT THE OCCLUSION. THE PATIENT HAD NO COMPLICATIONS AND WAS STABLE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8875345 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BECAME LOOSE . A SAVION FLX GUIDEWIRE WAS SELECTED FOR REVASCULARIZATION PROCEDURE IN THE POPLITEAL ARTERY. DURING THE PROCEDURE INSIDE THE PATIENT'S BODY, THE NITINOL PART OF THE TIP BECAME LOOSE AND WAS BARELY HANGING ON TO THE REST OF THE GUIDEWIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813180 ↗