BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 1031202 · Received April 17, 2008

    Report

    Report Number
    2024168-2008-00304
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE POLYMER AND CORE. THE GUIDE WIRE WAS SEPARATED 26.8 CM DISTAL TO THE PROXIMAL END OF THE POLYMER. THE DISTAL END OF THE SEPARATION WAS NOT RETURNED. THE POLYMER COATING WAS STRETCHED AND JAGGED AT THE SEPARATION. THE COILS WERE SLIGHTLY WAVY FOR A LENGTH OF 1.5 CM PROXIMAL TO THE SEPARATION. THERE WAS A KINK IN THE CORE 8 MM DISTAL TO THE PROXIMAL END OF THE CORE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETER OF THE GUIDE WIRE. THE OUTER DIAMETER MET MANUFACTURING CRITERIA. THE RETURNED GUIDE WIRE COULD NOT BE BACKLOADED THROUGH A NEW CATHETER DUE TO KINK IN THE CORE. THE DISTAL END OF THE GUIDE WIRE WAS DIPPED INTO CONGO RED DYE TO CONFIRM THAT THERE WAS HYDROPHILIC COATING PRESENT ON THE GUIDE WIRE. THE DEVICE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: SEPARATED GUIDE WIRE REMAINS IN THE PT. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PASS AN IN-STENT RESTENOSIS/OCCLUSION WITH THE WHISPER GUIDE WIRE, BUT IT WAS NOT POSSIBLE BECAUSE OF THE HEAVY CALCIFICATION. DURING THIS PROCEDURE, APPROXIMATELY 3 CM OF THE GUIDE WIRE TIP BROKE AND REMAIN STUCK IN THE CALCIFICATION LESION. THE VESSEL WAS OCCLUDED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PT IMPACT. NO OTHER INTERVENTION WAS DONE. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8010791

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S