BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2001933 · Received February 27, 2011

    Report

    Report Number
    2024168-2011-01231
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE CODE INADVERTENTLY NOT INCLUDED IN THE INITIAL REPORT SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT NOTED NO BLOOD VISIBLE BUT THERE WAS CONTRAST ON THE CORE AND POLYMER COATING. ANALYSIS CONFIRMED THE REPORTED KINK IN THE GUIDE WIRE AS THERE WAS A KINK IN THE GUIDE WIRE, 17.7 CM PROXIMAL TO THE TIP OF THE GUIDE WIRE. THE POLYMER COATING WAS SLIGHTLY TORN AT THE LOCATION OF THE KINK IN THE CORE. THE NOTED KINKS IN THE GUIDE WIRE AND TORN POLYMER COATING ARE CONSISTENT WITH INTERACTION WITHIN THE LESION ANATOMY DURING THE PROCEDURE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ANALYSIS COULD NOT CONFIRM THE REPORTED RESISTANCE WITH THE ANATOMY AS THE OUTER DIAMETER OF THE DISTAL TIP WAS MEASURED AND THE REMAINDER OF THE GUIDE WIRE WAS MEASURED AND ALL MET MANUFACTURING CRITERIA. RESISTANCE WITH THE ANATOMY CAN OCCUR DUE TO, BUT IS NOT LIMITED TO, LESION CHARACTERISTICS AND ANATOMICAL MORPHOLOGY OF THE PATIENT. IN THIS CASE, THE LESION WAS DESCRIBED AS CALCIFIED WITH 90% STENOSIS WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTY AS EXPLAINED ABOVE. OVERALL, A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED RESISTANCE AND THE REPORTED KINK IN THE GUIDE WIRE AND NOTED TORN POLYMER APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. ALL RETURNED PRODUCT ANALYSIS FINDINGS DO NOT SUGGEST A PRODUCT DEFICIENCY AS NO DAMAGE WAS NOTED PRIOR TO USE AND IS CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY DURING THE PROCEDURE. MANUFACTURING PERFORMS VISUAL INSPECTION AND PERFORMS OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS A RIGHT CORONARY ARTERY, CONCENTRIC AND CALCIFIED WITH 90% STENOSIS. DURING THE INSERTION OF A WHISPER MS, THE GUIDING CATHETER DISENGAGED FROM THE CORONARY ARTERY. SHORTLY AFTER THAT THE CONTROL OF THE WHISPER MS WAS DIFFICULT AND THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT. IT WAS NOTED THAT THE TIP APPROXIMATELY 20 CM PROXIMAL TO THE TIP BALL WAS FOUND TO BE KINKED. THERE WAS NO REPORTED PATIENT EFFECT. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED. RETURN DEVICE ANALYSIS REVEALED THE POLYMER COATING WAS SLIGHTLY TORN AT THE AREA OF THE KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 0111002

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: PROFIT 5FR JR4