BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO? SLIM

    MDR report key: 3895168 · Received June 25, 2014

    Report

    Report Number
    3005099803-2014-02312
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN; HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE 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 SLIM WAS USED DURING A HYSTEROPEXY WITH SACROSPINOUS LIGAMENT FIXATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT'S LEFT URETER DID NOT HAVE URINE OUTPUT. SO, THE PHYSICIAN PLACED A STENT. HOWEVER, THE PATIENT CONTINUES TO HAVE VOIDING ISSUES AND IS STILL IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371013 CAPIO? SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068318261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention