BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO¿

    MDR report key: 2211946 · Received August 15, 2011

    Report

    Report Number
    3005099803-2011-02699
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE 3088 RELATES TO 1104 FOR THE REPORTED EVENT OF "NEEDLE DETACHED."

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 POLYPROPYLENE 36-INCH SIZE 0 CAPIO SUTURE DURING A SACROSPINOUS FIXATION PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS.ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN ATTEMPTED TO THROW THE SUTURE THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE CARRIER FAILED TO EXTEND AND THE NEEDLE OF THE SUTURE DETACHED. THE DEVICE WAS USED SUCCESSFULLY FOR ONE THROW. ON THE SECOND THROW, THE PHYSICIAN FELT THAT THE NEEDLE CARRIER DID NOT EXTEND FULLY INTO THE CAPIO CAGE. THE DEVICE WAS PULLED OUT OF THE PATIENT AND THERE WAS NO SUTURE ATTACHED. THE PHYSICIAN THEN MANUALLY PULLED THE PROXIMAL END OF THE SUTURE OUT OF THE PATIENT AND WHEN HE REACHED THE DISTAL END OF THE SUTURE, HE FOUND NO NEEDLE ATTACHED. THE PHYSICIAN DETERMINED THAT THE NEEDLE WAS WELL EMBEDDED IN THE SACROSPINOUS LIGAMENT, AND IT WAS NOT REMOVED FROM THE PATIENT. THE PHYSICIAN THEN TESTED THE CAPIO DEVICE OUTSIDE OF THE PATIENT AND CONFIRMED THAT THE NEEDLE CARRIER ONLY EXTENDED HALFWAY INSTEAD OF FULLY TO THE CAGE. NO OTHER VISIBLE DEFECTS WERE NOTED ON THE DEVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NEW CAPIO DEVICE AND CAPIO SUTURE WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE AND THE CURRENT CONDITION WAS REPORTED AS "FINE."

    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 POLYPROPYLENE 36-INCH SIZE 0 CAPIO SUTURE DURING A SACROSPINOUS FIXATION PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE (B)(6). ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN ATTEMPTED TO THROW THE SUTURE THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE CARRIER FAILED TO EXTEND AND THE NEEDLE OF THE SUTURE DETACHED. THE DEVICE WAS USED SUCCESSFULLY FOR ONE THROW. ON THE SECOND THROW, THE PHYSICIAN FELT THAT THE NEEDLE CARRIER DID NOT EXTEND FULLY INTO THE CAPIO CAGE. THE DEVICE WAS PULLED OUT OF THE PATIENT AND THERE WAS NO SUTURE ATTACHED. THE PHYSICIAN THEN MANUALLY PULLED THE PROXIMAL END OF THE SUTURE OUT OF THE PATIENT AND WHEN HE REACHED THE DISTAL END OF THE SUTURE, HE FOUND NO NEEDLE ATTACHED. THE PHYSICIAN DETERMINED THAT THE NEEDLE WAS WELL EMBEDDED IN THE SACROSPINOUS LIGAMENT, AND IT WAS NOT REMOVED FROM THE PATIENT. THE PHYSICIAN THEN TESTED THE CAPIO DEVICE OUTSIDE OF THE PATIENT AND CONFIRMED THAT THE NEEDLE CARRIER ONLY EXTENDED HALFWAY INSTEAD OF FULLY TO THE CAGE. NO OTHER VISIBLE DEFECTS WERE NOTED ON THE DEVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NEW CAPIO DEVICE AND CAPIO SUTURE WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE AND THE CURRENT CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO¿ LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 0014033285

    Patients

    Seq Age Sex Outcome Treatment
    1 Other POLYPROPYLENE 36-INCH SIZE 0 CAPIO SUTURE