BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2060844 · Received April 18, 2011

    Report

    Report Number
    3005099803-2011-01260
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF "NEEDLE DETACHED."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SUTURE CAPTURING DEVICE WAS USED DURING A VAGINAL PELVIC FLOOR RECONSTRUCTION PROCEDURE. THE EXACT TYPE OF CAPIO DEVICE USED IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE NEEDLE OF A GORE-TEX SUTURE (NOT A BOSTON SCIENTIFIC DEVICE) DETACHED INSIDE THE PATIENT DURING THE PROCEDURE. IT WAS REPORTED THAT THE DETACHMENT OCCURRED AT THE NEEDLE AND THAT THE SEPARATION OCCURRED "AFTER A COUPLE OF STITCHES HAD BEEN THROWN THROUGH THE GRAFT." (GRAFT TYPE AND MANUFACTURER UNKNOWN.) AN X-RAY WAS TAKEN THE SAME DAY AS THE PROCEDURE BUT THE NEEDLE COULD NOT BE LOCATED. IT WAS REPORTED THAT THE NEEDLE HAS NOT BEEN LOCATED OR RETRIEVED SINCE THE INITIAL PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME CAPIO SUTURE CAPTURING DEVICE AND THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION WAS NOT SPECIFIED; HOWEVER, IT WAS STATED THAT "THERE WAS NO REPORTED PATIENT IMPACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI UNK55

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other GRAFT (TYPE AND MANUFACTURER UNKNOWN)| GORE-TEX SUTURE (NOT A BSC DEVICE)