BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2023925 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00708
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF "SUTURE NEEDLE DETACHED". ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS USED DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STAINLESS STEEL NEEDLE OF THE GORE SUTURE (NOT A BOSTON SCIENTIFIC PRODUCT) DETACHED INSIDE THE PATIENT DURING THE PROCEDURE. THE PATIENT HAD AN X-RAY, BUT THE EXACT LOCATION OF THE NEEDLE WAS NOT DETERMINED. THE NEEDLE HAS NOT BEEN RETRIEVED FROM THE PATIENT SINCE THE INITIAL PROCEDURE. IT IS UNKNOWN HOW THE INITIAL PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTEDLY "DOING FINE" POSTOPERATIVELY WITH NO COMPLICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other GORE SUTURE (NOT A BSC PRODUCT)