BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 1003527 · Received February 26, 2008

    Report

    Report Number
    2024168-2008-00144
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE COILS. THE CORE WAS DETACHED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS CORROSION PRESENT ON THE PROXIMAL SOLDER. THERE WERE SEVERAL OFFSET INTERMEDIATE COILS FOR A LENGTH OF 17 MM PROXIMAL TO THE CENTER SOLDER. THERE WAS A BEND IN THE SHAPING RIBBON 7 MM PROXIMAL TO THE TIPBALL. THERE WAS A KINK IN THE CORE AT THE PROXIMAL END OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRONIC MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE. THE SEM OF THE DEVICE CORE SHOWED EVIDENCE OF A HEAVY BEND ADJACENT TO THE HYPOTUBE. THE SEM ALSO SHOWED THE GUIDE WIRE FAILED FROM DUCTILE OVERLOAD. THE GUIDE WIRE WAS THEREFORE SUBJECTED TO FORCES THAT EXCEEDED THE STRENGTH OF THE DEVICE. THE INCIDENT INFORMATION DID NOT DESCRIBE EXACTLY HOW THE GUIDE WIRE WAS BENT, BUT THE HYPOTUBE JOINT, LOCATED 40 CM FROM THE TIP OF THE GUIDE WIRE, WILL EASILY BE DAMAGED IF KINKED. ONCE KINKED, THAT AREA WILL EASILY FRACTURE. IN CORONARY PROCEDURES, THIS AREA IS MORE SUPPORTED BY THE GUIDING CATHETER. THE DESIGN IS SUCH THAT IN A CORONARY PROCEDURE, THE GUIDE WIRE NEVER LEAVES THE GUIDING CATHETER. IN A RENAL APPROACH, THE GUIDE WIRE IS MORE VULNERABLE WITHOUT THE GUIDING CATHETER SUPPORT. PUSHING OR PULLING AGAINST RESISTANCE CAN CAUSE THE HYPOTUBE TO OVERBEND OR KINK AT THE HYPOTUBE JOINT. THE LAB ANALYSIS SHOWED OFFSET INTERMEDIATE COILS WHICH IS A SIGN THAT THE GUIDE WIRE TIP MET RESISTANCE. BASED ON THE OVERALL ANALYSIS, THE HYPOTUBE AREA OF THE GUIDE WIRE WAS KINKED AND THIS LIKELY PRECIPITATED THE WIRE FRACTURE. THE KINK MAY HAVE BEEN THE RESULT OF POOR WIRE SUPPORT AT THE HYPOTUBE JOINT IN CONJUNCTION WITH MOVING THE GUIDE WIRE AGAINST RESISTANCE. IF THERE WAS DIFFICULTY ADVANCING OR RETRACTING THE IVUS AS REPORTED, THIS COULD ALSO CONTRIBUTE TO A BEND/KINK OF THE HYPOTUBE AREA ESPECIALLY WITH NO GUIDING CATHETER FOR SUPPORT AND THE DIFFICULT ANATOMY IN A RENAL SITUATION. THE WIRE CORROSION, AS FOUND IN THE ANALYSIS, IS RELATED TO DETERIORATION IN TRANSIT BACK TO ABBOTT AND IS NOT RELATED TO THE ISSUE. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED, AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONAL: SEPARATED GUIDE WIRE REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: SEPARATED GUIDE WIRE. IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE ILIAC, AND HAD MILD TORTUOSITY. IN AN ATTEMPT TO PERFORM INTRAVASCULAR ULTRA SOUND (IVUS), THE BMW-HC GUIDE WIRE WAS DELIVERED TO THE LESION AND AN IVUS CATHETER WAS ADVANCED. AFTER PULL-BACK OF THE IVUS CATHETER WAS COMPLETED, THE WHOLE SYSTEM WAS REMOVED TO PREVENT THE IVUS AND THE BMW HC GUIDE WIRE FROM BEING BENT WHEN REMOVING THE IVUS CATHETER OVER THE GUIDE WIRE. WHEN THE DEVICES WERE EXAMINED OUTSIDE THE VESSEL, THE DISTAL PART OF THE BMW HC WAS MISSING. THEN, ON ANGIOGRAPHY, THE SEPARATED DISTAL PART OF THE BMW-HC WAS CONFIRMED TO BE REMAINING IN THE BRACHIAL ARTERY. THE SEPARATED PIECE OF GUIDE WIRE WAS RETRIEVED FROM THE VESSEL USING A SNARE DEVICE. THERE WAS NO RESISTANCE MET BETWEEN THE BMW-HC GUIDE WIRE AND THE IVUS CATHETER WHEN ADVANCING THE IVUS CATHETER, PULLING BACK THE IVUS TO EXAMINE THE LESION, OR WHEN REMOVING THE SYSTEM. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7030871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention