BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRA JAGWIRE?

    MDR report key: 3912679 · Received July 3, 2014

    Report

    Report Number
    3005099803-2014-02428
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02428 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE AND A WALLFLEX ENTERAL COLONIC STENT WERE USED IN THE TRANSVERSE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A 4 OR 5 CM MALIGNANT LESION AND TO RELIEVE A LARGE BOWEL OBSTRUCTION PRIOR TO COLECTOMY. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS AND THE LESION WAS RAISED AND TOTALLY OCCLUDED THE LUMEN OF THE TARGET AREA. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE HYDRA JAGWIRE TO THE LESION AND THE WALLFLEX ENTERAL COLONIC STENT WAS DEPLOYED. POST-PROCEDURE, THE PATIENT EXPERIENCED SEVERE PAIN. A CT IMAGE CONFIRMED A PERFORATION IN THE COLON. AN EMERGENCY LAPAROTOMY WAS PERFORMED AND THE PHYSICIAN NOTED THAT 3 OR 4 CM OF THE FLARED END OF THE STENT EDGE PROTRUDED FROM THE TRANSVERSE COLON TO THE ABDOMINAL CAVITY. A COLECTOMY SURGERY WAS ALSO PERFORMED AND THE STENT WAS REMOVED. ACCORDING TO THE PHYSICIAN, BOTH THE HYDRA JAGWIRE AND THE WALLFLEX COLONIC STENT PROTRUDED INTO THE ABDOMINAL CAVITY FROM THE COLON. REPORTEDLY, THE STENT HAD BEEN DEPLOYED PROTRUDING FROM THE COLON. THE PATIENT'S CONDITION FOLLOWING THE SURGERY WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390206 HYDRA JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556051

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention