BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOODMAN CO. LTD.

    MDR report key: 1051301 · Received May 22, 2008

    Report

    Report Number
    2243801-2008-00005
    Event Type
    Other
    Date Received
    May 22, 2008
    Report Date
    May 13, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. ONE USED CATHETER SAMPLE WITH A CONSIDERABLE AMOUNT OF DRIED BLOOD ON THE TUBING, ELECTRODES, AS WELL AS BALLOON WAS RETURNED. THERE WAS A SUTURE ON TUBING NEAR THE 50 CM MARK. ALSO THE CATHETER CAME INSERTED IN A HEMOSTASIS SHEATH INTRODUCER. THE FRENCH SIZE OF THE INTRODUCER COULD NOT BE LOCATED ON THE HUB OR ANYWHERE ON THE SHEATH. HOWEVER, THE INNER DIAMETER OF THE RETURNED INTRODUCER SHEATH MEASURED .073", INDICATING FRENCH SIZE 5. THE IFU SUPPLIED WITH THIS PRODUCT INSTRUCTS THE USER TO USE AT LEAST A ONE FRENCH SIZE LARGER INTRODUCER THAN THE CATHETER'S FRENCH SIZE. SINCE THE CATHETER IS A 5 FRENCH SIZE, A 6 FRENCH INTRODUCER SHEATH SHOULD HAVE BEEN UTILIZED. A CONTINUITY TEST WAS DONE ON THE CATHETER AND IT PASSED THE CONTINUITY TEST ON BOTH ELECTRODES. THERE WAS NO BREAKAGE OF CONTINUITY AT EITHER OF THE ELECTRODES AND THERE WAS NO SHORT CIRCUIT DETECTED. THE BALLOON WAS INFLATED VIA STANDARD INFLATION SYRINGE WITHOUT ANY DIFFICULTY. THE REPORTED INCIDENT COULD NOT BE DUPLICATED WITH THE RETURN SAMPLE.

    Description of Event or Problem · 1

    PACING FAILURE. (UNABLE TO PACE: IN USE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD. PACING CATHETER DYG B. BRAUN MEDICAL, INC. NA 60963887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other