BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3961521 · Received July 28, 2014

    Report

    Report Number
    3005099803-2014-02648
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. 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 #3005099803-2014-02597 AND 3005099803-2014-02648 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT AND A HYDRA JAGWIRE GUIDEWIRE WERE USED IN THE SIGMOID COLON DURING A COLONIC STENTING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED AS A BRIDGE TO SURGERY TO TREAT A 5CM STRICTURE DUE TO A MALIGNANCY. ACCORDING TO THE PHYSICIAN, THE PATIENT HAS NEVER UNDERGONE CHEMOTHERAPY NOR RADIOTHERAPY. THE STAGE OF CANCER PROGRESSION PRIOR TO THE PROCEDURE WAS STAGE II. REPORTEDLY, THE PATIENT'S TARGET ANATOMY OF THE SIGMOID WAS TORTUOUS. THE PATIENT FELT PAIN WHEN THE SCOPE WAS ADVANCED INTO THE COLON. ACCORDING TO THE COMPLAINANT, THE HYDRA JAGWIRE WAS PLACED AT THE STRICTURE SITE AFTER SOME DIFFICULTY ADVANCING. THE STENT WAS ADVANCED TO THE TARGET SITE AND THE PHYSICIAN BEGAN RELEASING THE STENT BUT RECONSTRIANED THE STENT ONCE DURING THE PROCEDURE. THE PHYSICIAN THEN DEPLOYED THE STENT. RADIOGRAPHY WAS PERFORMED AND NO SIGNS OF FREE AIR WERE DETECTED DURING STENT DEPLOYMENT. HOWEVER, AFTER THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE PATIENT¿S ABDOMEN WAS SWELLING. CT SCAN WAS IMMEDIATELY PERFORMED AND A PERFORATION WAS CONFIRMED AT THE DISTAL END OF THE STENT. SURGERY WAS IMMEDIATELY PERFORMED TO REMOVE THE STENT AND THE TUMOR, INCLUDING THE PERFORATED AREA. POST PROCEDURE, THE PATIENT WAS TRANSFERRED FROM THE ICU TO THE GENERAL WARD ON AN UNKNOWN DATE AND WAS STILL UNDER OBSERVATION. ACCORDING TO THE PHYSICIAN, IT WAS UNKNOWN WHICH OF THE DEVICES CAUSED THE PERFORATION OR WHEN THE PERFORATION OCCURRED DURING THE PROCEDURE. IN THE PHYSICIAN¿S ASSESSMENT, MANIPULATION OF THE DEVICES CONTRIBUTED TO THE PERFORATION SINCE THE ANATOMY WAS TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437873 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565110 0016879442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention