BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 2992977 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01318
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE CORRECTED. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND THE REPORTED SEPARATION WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. BASED ON VISUAL ANALYSIS AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NONCONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEVERE LEFT MAIN, OSTIAL LEFT ANTERIOR DESCENDING ARTERY (LAD), OSTIAL CIRCUMFLEX (CX) AND DISTAL CX DISEASE. THE TARGET AREAS WERE REPORTED TO BE HEAVILY CALCIFIED. THE WHISPER GUIDE WIRE TIP SEPARATED DURING USE. THE SEPARATED GUIDE WIRE TIP WAS ATTEMPTED TO BE SNARED. HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE SEPARATED TIP REMAINS IN THE PATIENT. THERE WAS GOOD FLOW THROUGHOUT THE PROCEDURE AND NO PERFORATION OR FLOW DISRUPTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96939 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 2100871

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other| R