BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1874200 · Received October 19, 2010

    Report

    Report Number
    3005099803-2010-04379
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE 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. THOUGH THE DEVICE EXPIRATION DATE IS UNAVAILABLE, THE COMPLAINANT STATED THAT THE DEVICE WAS NOT USED PAST EXPIRATION DATE. (B)(4) - REMOVAL OF FOREIGN BODY. (B)(4) - THE REPORTED ISSUE OF SUTURE DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR APICAL REPAIR PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE PHYSICIAN WAS IMPLANTING A PELVISOFT MESH (MANUFACTURED BY C. R. BARD INC.) WHEN THE CAPIO SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.) THAT WAS BEING USED TO SUTURE THE MESH DETACHED CLOSE TO THE NEEDLE END OF THE SUTURE. THE DETACHED PORTION OF THE SUTURE REPORTEDLY FELL INSIDE THE PATIENT, BUT WAS RETRIEVED BY HAND USING JUST VISUALIZATION. A SECOND SUTURE WAS THEN USED TO SUTURE THE MESH, HOWEVER, THIS SUTURE DETACHED AS WELL. THE DETACHMENT REPORTEDLY OCCURRED IN THE MIDDLE OF THE SUTURE AND NO PORTION OF THIS SUTURE FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE AND A THIRD SUTURE WITHOUT ANY FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention PELVISOFT MESH (MANUFACTURER: C. R. BARD INC)| CAPIO SUTURES (MANUFACTURER: TELEFLEX MEDICAL INC)