BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2102768 · Received May 25, 2011

    Report

    Report Number
    3005099803-2011-01891
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS USED WITH A POLYPROPYLENE 36-INCH SIZE 0 CAPIO SUTURE DURING A SACROSPINOUS FIXATION PROCEDURE. ACCORDING TO THE COMPLAINANT, TWO SUCCESSFUL THROWS WERE MADE WITH THE DEVICE. ON THE THIRD THROW, THE NEEDLE OF THE SUTURE DID NOT CATCH INSIDE THE CAPIO CAGE AND WHEN THE PHYSICIAN ATTEMPTED TO PULL THE SUTURE THROUGH THE TISSUE WITH THE DEVICE, THE NEEDLE OF THE SUTURE DETACHED IN THE SACROSPINOUS LIGAMENT. IT WAS REPORTED THAT SOME AMOUNT OF SUTURE WAS ATTACHED TO THE NEEDLE. THE PHYSICIAN ATTEMPTED TO PALPATE THE NEEDLE BUT WAS UNSUCCESSFUL. THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT. AT THIS POINT, THE FIXATION PROCEDURE HAD BEEN COMPLETED SO ANOTHER DEVICE WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 13903742

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention POLYPROPYLENE 36-INCH SIZE 0 CAPIO SUTURE