BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADICAL PROSTATECTOMY SUTURE CAPTURING DEVICE

    MDR report key: 1738794 · Received June 28, 2010

    Report

    Report Number
    3005099803-2010-02883
    Event Type
    Injury
    Date Received
    June 28, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A "PROSTATECTOMIA RADICAL" PROCEDURE USING A CAPIO RADICAL PROSTATECTOMY (RP) SUTURE CAPTURING DEVICE, THE CAPIO RP SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC.) "PIECEMEAL RELEASED." THE SUTURE THEN "BROKE IN MORE PIECES" AND "IT WAS NOT POSSIBLE TO RETRIEVE THE SUTURES" PRESUMABLY FROM INSIDE THE PATIENT. REPORTEDLY, THE PROCEDURE "HAS BEEN PERFORMED ANOTHER TIME WITH NO ADVERSE EFFECTS" AND WITH NO FURTHER COMPLICATIONS TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN FORTHCOMING FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADICAL PROSTATECTOMY SUTURE CAPTURING DEVICE HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - MIAMI M0068321010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CAPIO SUTURE (MANUFACTURER: TELEFLEX MEDICAL INC.)