BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 3080690 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02610
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: QUANTUM. GUIDE CATHETER: 6 FRENCH, GUIDELINER. STENT: XIENCE XPEDITION, RESOLUTE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHISPER GUIDE WIRE WAS USED IN A VERY TIGHT LESION IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS, SMALL OBTUSE MARGINAL CORONARY ARTERY AND THE CASE WAS VERY DIFFICULT. MULTIPLE WIRES, MULTIPLE BALLOONS, AND MULTIPLE STENTS WERE USED FOR THIS PROCEDURE. THE TIP OF THE WHISPER GUIDE WIRE SEPARATED DURING REMOVAL IN A SMALL CORONARY ARTERIAL BRANCH AND WAS UNABLE TO BE RETRIEVED VIA SNARE AND OTHER METHODS, DESPITE MULTIPLE ATTEMPTS TO REMOVE IT. THE TIP OF THE WIRE WAS LEFT IN THE SMALL BRANCH AND THE PHYSICIAN DID NOT THINK IT WOULD CAUSE PATIENT INJURY IN SUCH A SMALL BRANCH. THIS DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. REPORTEDLY, THE PATIENT HAS RECOVERED NORMALLY AND IS IN GOOD CONDITION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180857 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3011671

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention