SYNCHRO 14 M00313310Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 07613252186946), received between Jun 22, 2017 and Jan 5, 2026 — classified as 25 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fracture” (45 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Apr 23, 2024Open, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1909-2024 · Root cause: Process design · FDA record ↗

2. Apr 18, 2024Open, Classified

   Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

   Z-1939-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT SUBJECT GUIDEWIRE DISTAL TIP WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23964372 ↗
• MalfunctionJan 3, 2026Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT SUBJECT GUIDEWIRE DISTAL TIP WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952814 ↗
• InjuryOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR MIDDLE CEREBRAL ARTERY MCA STENOSIS, WHEN THE SUBJECT GUIDEWIRE WAS USED, THE PHYSICIAN FOUND IT UNCONTROLLABLE. ANGIOGRAPHY REVEALED THAT THE TIP OF THE SUBJECT GUIDEWIRE HAD FRACTURED. THE PROXIMAL SEGMENT OF THE GUIDEWIRE WAS THEN WITHDRAWN FOR RETRIEVAL, WHILE ATTEMPTS TO REMOVE THE FRACTURED DISTAL SEGMENT USING A SNARE WERE UNSUCCESSFUL, LEAVING IT INSIDE THE PATIENT'S BODY. THE PHYSICIAN DID NOT TAKE FURTHER ACTION REGARDING THE RETAINED FRAGMENT AND SUBSEQUENTLY COMPLETED THE PROCEDURE USING ANOTHER GUIDEWIRE. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 14-OCT-2025 STATED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS NOW TAKING ANTICOAGULANT MEDICATION AT HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 23300892 ↗
• InjuryMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION CASE, THE PHYSICIAN NAVIGATED THE SUBJECT GUIDEWIRE WITH AN MICROCATHETER TO THE TARGET SITE. ATTEMPTS TO GO THROUGH THE OCCLUSION WITH THE GUIDEWIRE, BUT THE DELIVERY WAS UNSUCCESSFUL AFTER MULTIPLE TRIES, AND IT WAS SUBSEQUENTLY NOTED THAT THE GUIDEWIRE TIP HAD FRACTURED WITHIN THE VESSEL. THE PHYSICIAN RETRACTED THE GUIDEWIRE, RETRIEVED THE FRACTURED SEGMENT USING OTHER DEVICE, AND REPLACED THE GUIDEWIRE TO SUCCESSFULLY COMPLETE THE RECANALIZATION. THE PROCEDURE CONCLUDED SMOOTHLY, AND THE PATIENT EXPERIENCED NO POSTOPERATIVE DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991360 ↗
• InjuryJan 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING VA BALLOON DILATION AND STENTING PROCEDURE, THE SUBJECT GUIDEWIRE GOT FRACTURED IN THE VESSEL. THE OPERATOR USED A VASCULAR FOREIGN BODY RETRIEVAL DEVICE TO TAKE THE FRACTURED GUIDEWIRE OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140329 ↗
• InjuryNov 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHEN DELIVERING THE SUBJECT GUIDEWIRE, TO BETTER ADJUST ITS POSITION, THE SUBJECT GUIDEWIRE WAS ROTATED PROXIMAL END OUTSIDE PATIENT'S BODY. WHEN THE SUBJECT GUIDEWIRE REACHED THE POSITION, THE DISTAL OF THE SUBJECT GUIDEWIRE WAS NOT ROTATING WITH THE PROXIMAL MOVEMENT. THEREFORE, THE SUBJECT GUIDEWIRE WAS WITHDRAWN AND FOUND THE DISTAL OF THE SUBJECT GUIDEWIRE WAS FRACTURED. 10CM OF THE FRACTURED TIP WAS LEFT INSIDE THE PATIENT'S BODY AND THE SNARE DEVICE WAS USED TO REMOVE THE FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772386 ↗
• MalfunctionNov 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT GUIDEWIRE WAS DELIVERING INTO THE MICROCATHETER AS AFTER SEVERAL ROTATIONS, THE TIP OF THE SUBJECT GUIDEWIRE WAS NOT MOVING. THE WHOLE SYSTEM WAS WITHDRAWN AND THE SUBJECT GUIDEWIRE WAS PULLED OUT FROM THE MICROCATHETER AS THE SUBJECT GUIDEWIRE WAS FRACTURED INSIDE THE MICROCATHETER. THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711089 ↗
• InjuryNov 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING LEFT VA V4 STENOSIS CASE, THE BALLOON CATHETER WAS USED TO DILATE AND STENT TO IMPLANT. THE GUIDEWIRE 3M WAS USED TO DELIVER THE BALLOON CATHETER TO THE STENOSIS, AND AFTER DILATION THE BALLOON CATHETER WAS WITHDRAWN, AS THE TIP OF THE SUBJECT GUIDEWIRE WAS FOUND TO BE FRACTURED. USED A SOLITAIRE AB STENT TO CATCH IT BUT UNSUCCESSFUL. FINALLY, THE OPERATOR DEPLOYED THE SOLITAIRE AB STENT AT THE STENOSIS (ALSO FIXED THE FRACTURED GUIDEWIRE) TO FINISH THE IMPLANTATION WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS NORMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20699172 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS, THE INVESTIGATION OF THE DEVICE REVEALED THAT THE DISTAL END OF THE SUBJECT GUIDEWIRE HAD BEEN FRACTURED . NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560183 ↗
• InjurySep 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTRACRANIAL ATHEROSCLEROSIS DISEASE (ICAD) PROCEDURE, THE SUBJECT GUIDEWIRE WAS USED TO SUPER SELECTED THE STENOSIS LESION. THE PATIENT'S VESSEL WAS EXTREMELY TORTUOUS AND DIFFUSE CALCIFICATION; THEREFORE, THE SUBJECT GUIDEWIRE WAS HARD TO BE ADVANCED. THE OPERATOR DECIDED TO FINISH THE PROCEDURE DIRECTLY BUT WHEN RETRACTING THE SUBJECT GUIDEWIRE, IT WAS FRACTURED ABOUT 15CM. THE OPERATOR TRIED TO USE A SNARE DEVICE TO RETRIEVE THE FRACTURED FRAGMENT BUT THE VESSEL WAS TOO TORTUOUS SO THE OPERATOR WAS AFRAID IT MAY RESULT IN OTHER COMPLICATION SO AFTER EVALUATION THE OPERATOR DECIDED NOT TO TAKE THE FRACTURED GUIDEWIRE OUT AND FINISHED THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. BASED ON THE PHYSICIAN¿S OPINION, THE PATIENT'S VESSEL WAS VERY TORTUOUS AS THE SUBJECT GUIDEWIRE FRACTURED WAS ANTICIPATED. THE CURRENT CONDITION OF THE PATIENT IS GOOD AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20181234 ↗
• MalfunctionSep 9, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED SUBJECT GUIDEWIRE DEVICE REVEALED THAT THE NITINOL TUBING OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173617 ↗
• InjuryAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY (ICA) OCCLUSION CASE, WHEN SUPER SELECTING SUBJECT GUIDEWIRE TO A2-A3 SEGMENT OF PATIENT¿S ANATOMY, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE GOT FRACTURED. OPERATOR ATTEMPTED TO USE A BALLOON AS MEDICAL INTERVENTION TO WORK WITH CATHETER TO RETRIEVE THE FRACTURED PART OF SUBJECT GUIDEWIRE OUT BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED AND SURGICAL DELAY OF 3 HOUR WAS OBSERVED. THE FRACTURED PART OF SUBJECT GUIDEWIRE WAS LEFT INSIDE THE PATIENT'S VESSEL. PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE CURRENT STATUS IS NOT AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19918001 ↗
• MalfunctionJul 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN MCA (MIDDLE CEREBRAL ARTERY) STENOSIS CASE, AFTER PUNCTURING THE RIGHT FEMORAL ARTERY AND PLACING THE CATHETER TO THE MCA (MIDDLE CEREBRAL ARTERY) M2 UNDER THE GUIDANCE OF THE SUBJECT GUIDEWIRE, ABNORMAL MANIPULATION WAS OBSERVED. THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE AND DISCOVERED THAT ITS HYDROPHILIC COATING HAD PEELED OFF. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779011 ↗
• MalfunctionJul 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN PUNCTURED A RIGHT FEMORAL ARTERY AND PLACED 8F ARTERY SHEATH. PHYSICIAN USED A SLIM GUIDEWIRE TO BRING A GUIDE CATHETER TO C1 AND THEN USED A MIDDLE CATHETER TO DELIVER THE SUBJECT GUIDEWIRE INTO THE MICROCATHETER. RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY OF THE SUBJECT GUIDEWIRE WITHIN THE MICROCATHETER SHAFT. THE PHYSICIAN WITHDRAW THE SUBJECT GUIDEWIRE AND FOUND THAT THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779010 ↗
• MalfunctionJul 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN PUNCTURED A RIGHT FEMORAL ARTERY AND PLACED 8F ARTERY SHEATH. PHYSICIAN USED A SLIM GUIDEWIRE TO BRING A GUIDE CATHETER TO C1 AND THEN USED A MIDDLE CATHETER TO DELIVER A GUIDEWIRE INTO THE MICROCATHETER. RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY OF THE GUIDEWIRE WITHIN THE MICROCATHETER SHAFT. THE PHYSICIAN WITHDRAW THE GUIDEWIRE AND FOUND THAT THE TIP OF THE GUIDEWIRE WAS FRACTURED. PHYSICIAN REPLACED THE GUIDEWIRE WITH THE SUBJECT GUIDEWIRE HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE DELIVERING THE SUBJECT GUIDEWIRE WITHIN THE MICROCATHETER. THE PHYSICIAN WITHDRAW THE GUIDEWIRE AND FOUND THAT THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779009 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING ONE LEFT M1 STENOSIS CASE, THE OPERATOR FLUSHED AND DELIVERED THE SUBJECT GUIDEWIRE TO C1 SEGMENT, AND THE DELIVERY WAS SMOOTH. HOWEVER, THE PATIENT'S VESSEL WAS QUITE TORTUOUS SO WHEN USED THE SUBJECT GUIDEWIRE TO REACH THE LESION, THE OPERATOR FELT TIP OF THE SUBJECT GUIDEWIRE WAS NOT ROTATING INSIDE PATIENT'S VESSEL. THE SUBJECT GUIDEWIRE WAS WITHDRAWN AND FOUND IT WAS FRACTURED. REPLACED IT WITH ANOTHER GUIDEWIRE TO CONTINUE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377351 ↗
• InjuryMay 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE BASILAR ARTERY STENOSIS PROCEDURE, FOLLOWING DELIVERY OF THE MICROCATHETER TO THE PROXIMAL OF THE OCCLUSION SEGMENT, AN ATTEMPT WAS MADE TO DELIVER THE SUBJECT GUIDEWIRE TO PASS THE OCCLUSION. HOWEVER THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS FOUND TO BE FRACTURED WHEN PASSING THROUGH THE OCCLUSION SEGMENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE SUBJECT GUIDEWIRE WITH THE MICROCATHETER BUT IT COULD NOT BE REMOVED. A BALLOON CATHETER WAS USED TO REACH THE FRACTURED SECTION OF THE SUBJECT GUIDEWIRE AND WAS DILATED TO CATCH THE SUBJECT GUIDEWIRE AND SUCCESSFULLY REMOVE IT FROM THE PATIENTS BODY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226640 ↗
• MalfunctionApr 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE OPERATOR ATTEMPTED TO USE THE SUBJECT GUIDEWIRE FOR DELIVERY. WHILE NAVIGATING TOWARD THE DISTAL STENOSIS, RESISTANCE WAS ENCOUNTERED. THE OPERATOR PROCEEDED AND THE SUBJECT GUIDEWIRE FRACTURED 15 CM FROM THE TIP, THE CORE WIRE REMAINED INTACT. THE SUBJECT GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210279 ↗
• InjuryMar 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE SUBJECT GUIDEWIRE WAS ALONG WITH THE A MICROCATHETER AND A INTERMEDIATE CATHETER TO BUILD ACCESS. DURING SUBJECT GUIDEWIRE DELIVERY, THE OPERATOR FELT RESISTANCE AND THE MANIPULATION OF THE GUIDEWIRE WAS NOT AGILE. THE OPERATOR TRIED TO WITHDRAW THE SUBJECT GUIDEWIRE AND RESISTANCE WAS ENCOUNTERED. THE DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) SHOWED VASOSPASM FOR A DURATION OF 15 MINS. AFTER SEVERAL TRIES THE OPERATOR RETRACTED THE SUBJECT GUIDEWIRE OUT AND FOUND THE DISTAL OF THE SUBJECT GUIDEWIRE FRACTURED. DSA SHOWED THE FRACTURED PART WAS LEFT INSIDE THE PATIENT'S VESSEL. THE OPERATOR TRIED TO USE RETRIEVER TO TAKE OUT THE FRACTURED PART BUT FAILED. FINALLY THE PROCEDURE WAS STOPPED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO TAKE ANOTHER PROCEDURE WAS PERFORMED TO TAKE OUT THE FRACTURED SUBJECT GUIDEWIRE AND FINISH THE THROMBECTOMY. IT WAS REPORTED THAT THE PATIENTS ANATOMY WAS SEVERELY TORTUOUS AND THERE WAS A SURGICAL DELAY OF 180 MINS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 18981042 ↗
• MalfunctionJan 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE OPERATOR FELT RESISTANCE WHEN ADVANCING THE SUBJECT GUIDEWIRE. THE SUBJECT GUIDEWIRE WAS WITHDRAWN FROM FROM THE PATIENTS VASCULAR ANATOMY AND THE SUBJECT GUIDEWIRE WAS FOUND TO BE FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574693 ↗
• InjuryOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING STENOSIS PROCEDURE, THE PATIENT VESSEL WAS VERY TORTUROUS, SO PHYSICIAN HAD DIFFICULTY IN DELIVERING THE MICROCATHETER TO THE TARGET LESION. DURING ADJUSTMENTS, THE PHYSICIAN CHECKED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND FOUND THAT THE DISTAL OF THE GUIDEWIRE WAS NOT MOVING TOGETHER WITH THE MANIPULATIONS AT THE PROXIMAL HANDLING. PHYSICIAN WITHDREW THE SUBJECT GUIDEWIRE AND FOUND THAT THE SUBJECT GUIDEWIRE DISTAL TIP WAS FRACTURED WITHIN THE PATIENT ANATOMY. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE FRACTURED GUIDEWIRE OUT. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044677 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE (SUBJECT DEVICE) DISTAL TIP BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037479 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ICAD PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE (SUBJECT DEVICE) WITHIN THE MICROCATHETER. UPON WITHDRAWAL OF THE GUIDEWIRE (SUBJECT DEVICE) THE TIP WAS FOUND TO BE FRACTURED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17945682 ↗
• MalfunctionOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING MIDDLE CEREBRAL ARTERY STENOSIS PROCEDURE, THE PHYSICIAN USED A BALLOON CATHETER TO DILATE. AFTER PLACING THE SUBJECT GUIDEWIRE AT THE TARGET LESION, THE TIP OF THE SUBJECT GUIDEWIRE COULD NOT ROTATE DURING TWISTING. THE PHYSICIAN FELT THAT THE SUBJECT GUIDEWIRE MIGHT BE FRACTURED. HOWEVER, A FOLLOW UP RESPONSE WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2023 CONFIRMING THAT THE SUBJECT GUIDEWIRE WAS STRETCHED AND NOT FRACTURED. LATER ON 03-OCT-2023 THE PRODUCT INVESTIGATION TEAM SHARED A PICTURE OF THE RETURNED SUBJECT GUIDEWIRE ALONG WITH FEW FOLLOW UP QUERIES REQUESTING FOR ADDITIONAL INFORMATION. THE PICTURE SHARED CONFIRMED THAT SUBJECT GUIDEWIRE WAS BROKEN. THE INVESTIGATION OF THE SUBJECT GUIDEWIRE IS ANTICIPATED BUT NOT YET BEGUN. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901711 ↗
• InjurySep 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE OPERATOR USED THE SUBJECT GUIDEWIRE TO BRING A CATHETER TO PASS THE DISSECTION ANEURYSM TO RIGHT PCA (POSTERIOR CEREBRAL ARTERY) P1 SEGMENT. THE PATIENT'S VESSEL WAS NOTED TO BE TORTUOUS. THE OPERATOR DELIVERED A STENT CATHETER FOR SEVERAL TRIES BUT FAILED TO DELIVER IT TO THE LOCATION SO WITHDREW IT AND REPLACED WITH ANOTHER CATHETER. THE OPERATOR DELIVERED THE SUBJECT GUIDEWIRE AGAIN TO EXCHANGE STENT CATHETER BUT DURING THIS PROCEDURE THE TIP 20CM OF THE SUBJECT GUIDEWIRE FRACTURED INSIDE RIGHT VA (VERTEBRAL ARTERY). THE PROCEDURE WAS STOPPED AND A NEUROSURGERY WAS PERFORMED TO CUT THE VESSEL AND REMOVED THE FRACTURED SUBJECT GUIDEWIRE FROM THE PATIENT. A SURGICAL DELAY OF 300 MIN WAS REPORTED DUE TO THIS EVENT. THE PATIENT'S CURRENT CONDITION WAS STABLE AND THE PATIENT RETURNED TO GENERAL WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848688 ↗