BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS RX-JAPAN

    MDR report key: 1933410 · Received December 3, 2010

    Report

    Report Number
    1220452-2010-00069
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC INC
    Product Code
    NFA
    PMA / PMN Number
    K023303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. THE EXTENSION WIRE OF THE OCCLUSION BALLOON IS KINKED 4CM PROXIMAL TO THE POSITIVE STOP. THE OCCLUSION BALLOON IS DAMAGED. THE OCCLUSION BALLOON MATERIAL IS SEPARATED FROM THE DISTAL SEAL. THE TIP OF THE OCCLUSION BALLOON SHOWS STRETCHING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MANUFACTURING PROCESS. THE EVENT HAS BEEN CONFIRMED FOR RUPTURE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE THE OCCLUSION BALLOON DEFLATED. BASED ON THE ACTUAL DEVICE BEING RETURNED THE DETERMINATION HAS BEEN MADE THAT THIS IS REPORTABLE EVENT. THE MADE AWARE DATE IS (B)(6) 2010. AT SOME POINT DURING THE PROCEDURE THE OCCLUSION BALLOON DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS RX-JAPAN NFA MEDTRONIC INC NA 0004076840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA