BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE ACC.KIT W/COPILOT

    MDR report key: 3132258 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03331
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DTL
    PMA / PMN Number
    K991102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED LEAK COULD NOT BE CONFIRMED VIA RETURNED DEVICE ANALYSIS. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PREPARING TO BEGIN THE PROCEDURE, LEAKING WAS NOTED ALTHOUGH THE CLAMP SEAL OF COPILOT BLEEDBACK CONTROL VALVE WAS CLOSED. THE PROCEDURE WAS FINISHED BY USING A NON-ABBOTT DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237446 GUIDE WIRE ACC.KIT W/COPILOT HEMOSTATIC VALVE DTL AV-TEMECULA-CT 2121301

    Patients

    Seq Age Sex Outcome Treatment
    1