BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 4251639 · Received November 14, 2014

    Report

    Report Number
    3005099803-2014-03599
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. ALTHOUGH THE EVENT OCCURRED DURING A U9920 - XENFORM STUDY PROCEDURE, THE XENFORM WAS NEVER USED DUE TO THE INJURY. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (EVENT DATE). ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PATIENT SUSTAINED A BLADDER INJURY DURING A PROCEDURE. IT WAS REPORTED THAT DURING THE DISSECTION, A CAPIO DEVICE WAS USED TO PLACE A SUTURE INTO THE LEFT SACROSPINOUS LIGAMENT WHEN A SUSPICIOUS FLUID WAS NOTICED IN THE VAGINAL INCISION. SUSPICIOUS OF A BLADDER INJURY, THEY REMOVED THE URETHRAL CATHETER AND A CYSTOSCOPE WAS PLACED. THEY FOUND THAT A BLADDER INJURY WAS SUSTAINED. THE SUTURE WAS SEEN IN THE BLADDER. THE CAPIO DEVICE WAS RETRACTED AND THE SUTURE REMOVED FROM THE PATIENT. SURGICAL INTERVENTION INVOLVING A BLADDER REPAIR AS WELL AS THE PLACEMENT OF A LEFT URETERAL STENT WAS REQUIRED TO TREAT THE INJURY. THE PATIENT WAS HOSPITALIZED OVER NIGHT FOR OBSERVATION AFTER THE SURGERY AND RELEASED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737268 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MARLBOROUGH UNK55

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention