BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1365223 · Received March 6, 2009

    Report

    Report Number
    2024168-2009-00379
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 4, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD VISIBLE ON THE TIP COILS. THERE WAS CONTRAST VISIBLE ON THE TIP COILS AND ON THE POLYMER COATING. THERE WAS CORROSION ON THE TIPBALL. THERE WAS A BEND IN THE TIP, 7 MM PROXIMAL TO THE TIPBALL. THE BLUE POLYMER COATING WAS TORN, 10.1 CM PROXIMAL TO THE PROXIMAL SOLDER FOR A LENGTH OF 8.7 CM. A PORTION OF THE TORN POLYMER COATING WAS WRAPPED AROUND THE INTERMEDIATE COILS, 1.1 CM DISTAL TO THE PROXIMAL SOLDER. THERE WAS A PORTION OF THE POLYMER COATING PEELED OF THE CORE, 1.5 CM PROXIMAL TO THE PROXIMAL SOLDER FOR A LENGTH OF 3.5 CM. THERE WERE THERE BENDS IN THE CORE, 55 CM, 61 CM AND 64 CM DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE DISTAL END OF THE GUIDE WIRE, INCLUDING THE HYPOTUBE WAS PASSED THROUGH A HOLE GAUGE, BUT THE GUIDE WIRE WOULD NOT ADVANCE PAST THE POLYMER COATING ON THE INTERMEDIATE COILS. THIS DID NOT MEET MANUFACTURING CRITERIA. THE PROXIMAL END OF THE GUIDE WIRE, UP TO THE HYPOTUBE, WAS PASSED THROUGH A HOLE GAUGE AND THIS MET MANUFACTURING CRITERIA. THE TIP WAS TUGGED ON TO CONFIRM THAT THE SHAPING RIBBON AND CORE WERE INTACT. THE RETURNED GUIDE WIRE WAS BACK LOADED THROUGH A NEW BALLOON CATHETER, BUT THE GUIDE WIRE WOULD NOT ADVANCE PAST THE INTERMEDIATE COILS DUE TO THE POLYMER COATING ON THE INTERMEDIATE COILS. PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: PEELING OF THE GUIDE WIRE COATING IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: PEELING OF COATING. IT WAS REPORTED THAT THE TIP OF THE GUIDE WIRE WAS KINKED AS IT WAS BEING ADVANCED TO THE BLOCKED VESSEL [CTO]. REPORTEDLY THERE WERE NO PT EFFECTS. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE. THIS IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED GUIDE WIRE, WHICH REVEALED THAT THE POLYMER COATING ON THE GUIDE WIRE WAS PEELING. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL REPORTED THAT THE GUIDE WIRE WAS DIFFICULT TO REMOVE AND FORCE WAS USED DURING REMOVAL AND THERE WAS NO POLYMER LEFT BEHIND IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8102391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK