SAVION FLX™ H749394223001J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729978824), received between Jan 2, 2019 and Jul 18, 2024 — classified as 18 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BROKE. THE PATIENT WAS BEING TREATED FOR CRITICAL LIMB ISCHEMIA. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A SAVION FLX GUIDEWIRE WAS USED DURING VASCULAR ANGIOPLASTY. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE TIP OF THE GUIDEWIRE BROKE. THE FRACTURED PORTION OF THE DEVICE WAS PULLED AND REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777611 ↗
• InjuryMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE ALONG WITH AN 0.14 RUBICON GUIDE CATHETER TO CROSS THE OCCLUDED ANTERIOR TIBIAL ARTERY. HOWEVER, THE TIP OF THE WIRE SNAPPED OFF IN THE OCCLUDED VESSEL. THE PHYSICIAN HAS NO PLANS IN REMOVING THE DETACHED FRAGMENT AS THE PATIENT WILL BE IN GREATER RISK IN TRYING TO RETRIEVE IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WIRE. NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE POST PROCEDURE AND FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19346944 ↗
• InjuryJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA). AN 18 OPTICROSS PERIPHERAL CATHETER WAS PLACED IN THE LEFT LEG ANTE-GRADE STICK OVER A 0.014 SAVION FLX GUIDEWIRE. WHILE USING THE INTRAVASCULAR ULTRASOUND (IVUS), THE TRANSDUCER ELEMENT WENT OUT WHILE IMAGING THE ARCH OF THE FOOT. HOWEVER, IT WAS NOTED THAT APPROXIMATELY 10 CM OF THE DISTAL END OF THE IVUS CATHETER HAD FRACTURED OFF INSIDE THE ARTERY UPON REMOVING THE DEVICE. AFTER THE DEVICE WAS REMOVED, IT WAS ALSO NOTED THAT A SMALL PIECE OF THE SAVION FLX GUIDEWIRE WAS IN THE ATA. A SNARE WAS USED TO RETRIEVE THE PIECE OF SAVION WIRE AND 18 OPTICROSS PERIPHERAL CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239150 ↗
• InjuryFeb 22, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING ARTERIAL PERIPHERAL VASCULAR PROCEDURE, THE DEVICE WAS FRACTURED. ATTEMPTS WERE MADE TO SNARE THE REMAINDER OF THE DEVICE AND AN ADDITIONAL FEMORAL ACCESS AND ADDITION SUPPLIES WERE NEEDED TO SNARE FROM A DIFFERENT APPROACH ALONG WITH APPROXIMATELY AN ADDITIONAL HOUR OF PROCEDURE TIME. EVENTUALLY, THE WIRE WAS STRAIGHTENED BY MULTIPLE MANIPULATIONS. THE FRACTURED PIECES WERE REMOVED BY A PEDAL ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE, AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421799 ↗
• MalfunctionMar 12, 2022Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED THROUGH SAVION FLX GUIDEWIRE; HOWEVER, THE BALLOON WOULD NOT ADVANCE OVER WIRE. THE DEVICE WAS REMOVED AND INSERTED A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER BUT STILL IT WOULD NOT ADVANCE, AND THE WIRE FELT STICKY. THE WIRE AND BALLOON WERE REMOVED TOGETHER, HOWEVER, THE MIDDLE TO DISTAL PART OF THE WIRE COATING WAS SHEAR OFF AND THE BALLOON WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON AND GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742302 ↗
• MalfunctionMar 9, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER BECAME STUCK ON THE GUIDEWIRE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER AND SAVION FLX GUIDEWIRE WERE SELECTED FOR USE. THE COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BECAME STUCK ON THE SAVION FLX GUIDEWIRE AND THE BALLOON CATHETER BECAME KINKED. BOTH DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH A NEW SAVION GUIDEWIRE AND COYOTE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711424 ↗
• InjuryJan 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT LATERAL PLANTAR ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE TIP OF SAVION FLEX BROKE OFF WHILE NAVIGATING THE MODERATELY TORTUOUS AND CALCIFIED PLAQUE. THE TIP WAS SUCCESSFULLY SNARED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285064 ↗
• InjuryJan 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE TIP DETACHED. A SAVION FLX WIRE WAS SELECTED FOR A PROCEDURE IN THE TOTALLY OCCLUDED LESION IN THE SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. THE PHYSICIAN HIGHLY MANIPULATED THE SAVION FLX WIRE IN AN ATTEMPT TO ENTER THE LESION. THE SAVION FLX WIRE WAS UNABLE TO ENTER THE LESION DUE TO THE SEVERE CALCIFICATION. THE SAVION FLX WIRE WAS REMOVED TO ATTEMPT A NEW WIRE. UPON REMOVING THE SAVION FLX WIRE, IT WAS OBSERVED THAT THE TIP OF THE WIRE WAS DETACHED AND REMAINING INSIDE THE PATIENT. AS THE VESSEL WAS ALREADY OCCLUDED, THE TIP FRAGMENT WAS NOT CAUSING ANY PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A NEW SAVION FLX WIRE. THE PATIENT WAS OK POST PROCEDURE. IT WAS FURTHER REPORTED THAT: THE PROCEDURE TEAM TRIED TO CATCH THE TIP FRAGMENT WITH A LASSO BUT IT DID NOT WORK BECAUSE IT WAS SUCH A SMALL FRAGMENT. THE PATIENT HAS SINCE BEEN DISCHARGED HOME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11227385 ↗
• InjuryJan 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. A SAVION FLX GUIDEWIRE WAS USED. HOWEVER, THE GUIDEWIRE DETACHED IN THE ANTERIOR TIBIAL ARTERY (AT) WHILE A 2.5 X 220 COYOTE BALLOON CATHETER WAS BEING USED. A PEDAL APPROACH WAS OBTAINED AND IT ATTEMPTED TO RETRIEVE THE WIRE WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 11109058 ↗
• InjuryOct 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINED IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY BELOW THE KNEE. DURING THE PROCEDURE, A SAVION FLX GUIDEWIRE WAS ADVANCED, BUT FAILED TO CROSS THE LESION DESPITE MULTIPLE ATTEMPTS. DURING REMOVAL, THE TIP BROKE OFF AND STAYED IN A CURVE OF THE AT VESSEL AT THE LESION. THE VESSEL HAD NO OUTFLOW SO THE PHYSICIAN DECIDED TO LEAVE THE TIP. THE PROCEDURE WAS ABORTED AFTER MULTIPLE ATTEMPTS TO ACCESS THE PEDAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10635241 ↗
• InjuryAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED INSIDE A PATIENT DURING A PROCEDURE. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PEDAL ARCH. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. THE GUIDEWIRE WAS SUCCESSFULLY PREPPED AND A 2X40 COYOTE BALLOON WAS ADVANCED OVER THE WIRE WITHOUT ISSUE. THE WIRE AND THE BALLOON WERE ADVANCED INTO THE PEDAL ARCH. THE WIRE WAS ALWAYS OUT IN FRONT OF THE BALLOON WHILE ADVANCING. DURING REMOVAL OF THE BALLOON OVER THE WIRE, THE TIP OF THE WIRE HAD DETACHED IN THE DISTAL LATERAL PLANTAR ARTERY. THE TIP OF THE WIRE WAS REMOVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A GOOD RESULT AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 10448912 ↗
• InjuryAug 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINS IN THE PATIENT. THE CHRONIC TOTAL OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR PEDAL LOOP ARTERY. A SAVION FLX WAS SELECTED FOR USE. DURING ADVANCEMENT TO THE LESION WITH HEAVY MANIPULATION, THE TRANSITION POINT AT THE TIP OF THE WIRE BROKE OFF IN THE PATIENTS FOOT. ATTEMPTS TO RETRIEVE THE WIRE TIP WERE MADE USING A SNARE, BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVION WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENTS STATUS POST PROCEDURE WAS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10437017 ↗
• InjuryJul 9, 2020Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT A TIP BREAK OCCURRED AND THE TIP REMAINED IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED POPLITEAL ARTERY. A SAVION GUIDEWIRE WAS SELECTED FOR USE. DURING ADVANCEMENT TO THE LESION, THE GUIDEWIRE HAD TO BE MANIPULATED TO PASS THE STENOSIS AND THE FIRST 1CM OF THE TIP BROKE. AN ATTEMPT WAS MADE TO SNARE THE TIP OF THE WIRE; HOWEVER WAS UNSUCCESSFUL AND THE TIP OF THE GUIDEWIRE REMAINED IN THE PATIENT. A DIFFERENT GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10253471 ↗
• InjuryJun 11, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED INSIDE THE PATIENT. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A PROCEDURE. WHILE CROSSING THE PEDAL PLANTAR LOOP, THERE WAS NO HEAVY CALCIUM, BUT THE GUIDEWIRE BENT BACK ON ITSELF, AND THE DISTAL TIP OF THE GUIDEWIRE DETACHED IN THE DISTAL ANTERIOR TIBIAL ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE GUIDEWIRE FRAGMENT WITH A NON-BSC SNARE. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143770 ↗
• InjuryJun 10, 2020Detachment of Device or Device Component; 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. WHILE WORKING IN THE DISTAL POSTERIOR ARTERY, WHICH WAS ROUGHLY 2.5MM AND OCCLUDED, THE TIP OF THE GUIDEWIRE DETACHED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE GUIDEWIRE FRAGMENT WITH A SNARE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10139348 ↗
• MalfunctionJun 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE A PATIENT DURING A PROCEDURE. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A RIGHT LET ARTERIAL CASE VIA LEFT WRIST ACCESS. THE PATIENT HAD TORTUOUS ANATOMY AND WHILE ATTEMPTING TO EXCHANGE THE GUIDEWIRE, THE TIP BROKE OFF INSIDE THE SHEATH. THE PHYSICIAN WAS ABLE TO SNARE THE WIRE FRAGMENT AND COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10139255 ↗
• InjuryMay 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE BUCKLED ON THE UNSPECIFIED BALLOON CATHETER AND SNAPPED OFF INSIDE THE PATIENT. A SNARE WAS USED TO REMOVE THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available

  MAUDE report 10051694 ↗
• MalfunctionMay 4, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON SYSTEM BECAME STUCK ON THE GUIDEWIRE. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE ALONG WITH A 2X40X144 COYOTE ES 2X40X144 BALLOON CATHETER FOR A TIBIAL INTERVENTION PROCEDURE IN THE RIGHT POSTERIOR TIBIAL ARTERY. DURING THE PROCEDURE, THE WIRE WAS UNABLE TO BE PULLED FROM THE CATHETER. IT WAS REPORTED THAT THERE WAS MATERIAL FROM TOWELS NEARBY ACCUMULATING ON THE SAVION FLX WIRE WHICH CREATED A STICKING POINT ON THE WIRE. THE WIRE AND BALLOON SYSTEM WERE REMOVED TOGETHER FROM THE PATIENT BODY, AND THE WIRE WAS REMOVED FROM THE PROXIMAL END OF THE BALLOON INSTEAD OF FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON DEVICE AND A NEW WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020899 ↗
• InjuryApr 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE IN THE 50% STENOSED RIGHT ANTERIOR TIBIAL ARTERY (ATA). WHILE TRYING TO NAVIGATE THE CALCIFIED ATA, THE GUIDEWIRE TIP DETACHED. IVUS SHOWED THAT THE FRAGMENT WAS NOT IN THE VESSEL LUMEN. THE PHYSICIAN THOUGHT THE DETACHED TIP OCCURRED BECAUSE THE WIRE WAS IN A DISSECTION PLANE OF THE CALCIFIED ARTERY. IT WAS DECIDED THAT IT POSED NO RISK OF BEING IN THE FALSE LUMEN SO IT WAS NOT RETRIEVED. A DIFFERENT GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS ONLINE BLOOD FLOW TO THE FOOT AND THREE VESSEL TIBIAL RUNOFF. THE PATIENT CONDITION POST-PROCEDURE WAS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 9985976 ↗
• InjuryFeb 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINED IN THE PATIENT. VASCULAR ACCESS TO THE LOWER LEG WAS ATTEMPTED VIA AN ANTEGRADE APPROACH FROM THE GROIN. A .018" NON-BSC GUIDEWIRE WAS INSERTED TO PROBE THE LOWER RIGHT LEG OF THE ANTERIOR TIBIALIS POSTERIOR ARTERY, BUT THE VESSEL WAS CLOSED. SEVERAL GUIDEWIRES AND A 0.18 RUBICON SUPPORT CATHETER WERE USED TO TRY TO OPEN THE VESSEL WITHOUT SUCCESS. A SAVION FLX GUIDEWIRE AND A RUBICON CATHETER WERE ADVANCED TO THE LESION IN AN ATTEMPT TO OPEN THE VESSEL. 11MM OF THE TIP OF THE GUIDEWIRE DETACHED. THE DETACHED FRAGMENT REMAINED IN THE VESSEL SINCE THE VESSEL WAS CLOSED. THE PROCEDURE WAS CANCELED AND NO FURTHER ATTEMPTS WERE MADE. THERE WERE FURTHER PATIENT COMPLICATIONS. THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE LESION WAS A LONG SEGMENT OCCLUSION WITH NO TORTUOSITY AND HIGH GRADE CALCIFICATION. THE WIRE TIP DETACHED IN THE FIRST SEGMENT WHEN PASSING THROUGH THE LESION WITH MINIMAL FORCE. THE VESSEL WAS TOO SMALL TO RETRIEVE THE DETACHED TIP FRAGMENT. RE-OCCLUSION OF THE VESSEL OCCURRED AFTER A FEW DAYS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9758230 ↗
• InjuryDec 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BROKE OFF DURING A PROCEDURE. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A PROCEDURE AND DURING THE ATTEMPT TO CROSS THE RIGHT LEG LATERAL PLANTAR IN THE FOOT, APPROXIMATELY 5MM OF THE DISTAL TIP OF THE WIRE BROKE OFF IN THE PATIENT'S ARTERY. THE PHYSICIAN USED A CORONARY SNARE TO REMOVE THE WIRE FRAGMENT. THE PROCEDURE WAS COMPLETED USING A NON-BSC WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available

  MAUDE report 9488631 ↗
• InjuryDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED INSIDE THE PATIENT. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BELOW THE KNEE. AS THE GUIDEWIRE WAS ADVANCED INTO THE PATIENT, IT WAS DIFFICULT TO EXPLORE THE VESSEL BELOW THE KNEE AND INTO THE ANTERIOR TIBIAL ARTERY BECAUSE THE GUIDEWIRE WENT SUBINTIMAL. DURING THE PROCEDURE THE GUIDEWIRE TIP DETACHED INSIDE THE PATIENT 2CM FROM THE TIP. THE DETACHMENT OCCURRED BELOW THE KNEE IN THE ANTERIOR TIBIAL ARTERY. THE DETACHED TIP WAS REMOVED WITH A SNARE. A NEW DEVICE, SAME MODEL, WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453193 ↗
• MalfunctionJun 18, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE'S PACKAGE WAS NOT SEALED. IT WAS OBSERVED DURING PREPARATION OF A SAVION FLX GUIDEWIRE THE SEAL ON THE INTERNAL PACKAGING WAS OPENED. THE GUIDEWIRE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 8707946 ↗
• MalfunctionMay 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE OFF INSIDE THE PATIENT. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE IN A HYBRID ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT. THE TIP OF WAS RETRIEVED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569822 ↗
• MalfunctionApr 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE BROKE INSIDE THE PATIENT. A SAVION FLX GUIDEWIRE WAS SELECTED FOR A LOWER EXTREMITY INTERVENTION. AS THE PHYSICIAN WAS TRYING TO CROSS THE LESION, THE WIRE BROKE. THE ENTIRE WIRE WAS THEN RETRIEVED FROM THE PATIENT. THE PATIENT EXPERIENCED NO COMPLICATIONS AND WAS FINE POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527898 ↗