BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2111460 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01890
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    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 PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT DURING AN ANTERIOR REPAIR PROCEDURE. THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-01833. THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. ACCORDING TO THE COMPLAINANT, TWO SUCCESSFUL THROWS WERE MADE WITH THIS DEVICE. ON THE THIRD THROW, THERE WAS DIFFICULTY PULLING THE SUTURE THROUGH THE TISSUE. WHEN THE PHYSICIAN ATTEMPTED TO PULL THE SUTURE THROUGH, THE NEEDLE OF THE SUTURE DETACHED WITH 2 CM OF SUTURE STILL ATTACHED TO THE NEEDLE. THIS OCCURRED NEAR THE VAGINA BUT OUTSIDE THE PATIENT WHILE THE SUTURE WAS BEING PULLED OUT. THE DETACHED PORTION OF THE SUTURE WAS CAPTURED INSIDE THE CAPIO CAGE. IT WAS REPORTED THAT THE NEEDLE CARRIER OF THE DEVICE APPEARED BENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO DEVICE. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    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 13746633

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT