BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 3854184 · Received June 6, 2014

    Report

    Report Number
    2024168-2014-03635
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HEAVY CALCIFIED RESTENOSIS (99%-100%) IN THE MID TO DISTAL PART OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LAD WAS WIRED WITH A WHISPER ES CORONARY GUIDE WIRE. THE STRATEGY WAS TO REVASCULARIZE THE LAD BY IMPLANTATION OF SEVERAL DRUG-ELUTING STENTS (DES). THE LONG CALCIFIED LESION WAS PRE-DILATED WITH UNSPECIFIED SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS. THEN A XIENCE 2.5 X 38 MM STENT WAS IMPLANTED IN THE MID PART OF THE LESION WITH A GOOD RESULT. BUT THE DISTAL LESION ALSO HAD TO BE TREATED AND AN ATTEMPT WAS MADE TO PRE-DILATE THIS DISTAL LESION, WITH NO SUCCESS, AS NO BALLOONS (SEMI-COMPLIANT, NON-COMPLIANT OR CUTTING) OR DES COULD CROSS THE DISTAL LESION. AFTER THAT, THE WHISPER ES GUIDE WIRE WAS GOING TO BE RETRACTED AND IT WAS NOTICED THAT THE DISTAL SECTION OF THE GUIDE WIRE HAD SEPARATED (APPROXIMATELY 15 CM). NO RESISTANCE WAS ENCOUNTERED PRIOR TO THE GUIDE WIRE SEPARATION. A SNARE WAS USED IN AN ATTEMPT TO RETRIEVE THE SEPARATED PART OF THE GUIDE WIRE; HOWEVER IT WAS UNSUCCESSFUL AND A LARGE SECTION OF THE GUIDE WIRE REMAINS IN THE LAD. THE PATIENT IS REPORTED TO BE FINE AND WILL NOT BE TREATED WITH SURGERY OR ANY OTHER INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331263 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 4031971

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: XIENCE 2.5 X 38 MM