BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 3232287 · Received July 9, 2013

    Report

    Report Number
    3003910212-2013-00019
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 11, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. BASED UPON THE AVAILABLE INFORMATION, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESS IN THE PRECAUTIONS AND ADVERSE REACTIONS SECTIONS OF THE INSTRUCTIONS-FOR-USE WITH THE FOLLOWING STATEMENTS, "MISUSE OF THIS SUTURE, LIKE ANY OTHER SUTURE, CAN RESULT IN SEVERE INJURY OR DEATH TO THE PATIENT. CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. NEEDLES ARE NOT INTENDED TO BE IMPLANTED. BROKEN NEEDLES OR DAMAGED SUTURE THREAD MAY RESULT IN EXTENDED OR ADDITIONAL SURGERY OR RETAINED FOREIGN BODIES". ALL AVAILABLE INFO HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GORE-TEX SUTURE WAS BEING USED WITH A CAPIO SUTURE CAPTURING DEVICE DURING A GYNECOLOGICAL PROCEDURE (BLADDER SLING) WHEN THE NEEDLE SEPARATED FROM THE SUTURE. IT WAS REPORTED THAT AT SOME POINT THE SUTURE WAS NOT BEING RECAPTURED BY THE CAPIO DEVICE. WHEN THE SUTURE WAS FINALLY RECAPTURED, IT WAS REPORTED THAT THE NEEDLE WAS NO LONGER ATTACHED TO THE SUTURE. IMAGING CONFIRMED THAT THE NEEDLE WAS IN THE PT, HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN DETERMINED AN ATTEMPT AT RETRIEVAL MAY POTENTIALLY CREATE MORE COMPLICATIONS THAN IF THE NEEDLE WAS LEFT IN PLACE. THE NEEDLE REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314373 GORE-TEX SUTURE GAW/ SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W.L. GORE & ASSOCIATES, INC 10913529

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other