BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT SUPERSTIFF GUIDEWIRE

    MDR report key: 2161375 · Received July 13, 2011

    Report

    Report Number
    3005099803-2011-02316
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    DQX
    PMA / PMN Number
    K760944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, THE PATIENT IS (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). A VISUAL EXAMINATION OF THE RETURNED GUIDEWIRE REVEALED THAT THE GUIDEWIRE PRESENTED EXTENSIVE BEND DAMAGE AND A FRACTURE OF THE CORE WIRE. THE FRACTURE REGION PRESENTS REDUCED CROSS-SECTIONAL AREA AND ANGLED FRACTURE FACES SUGGESTING DUCTILE, TENSILE OVERLOAD WITH TORSIONAL LOADING. THE SPECIMEN ALSO PRESENTS VARIED, RANDOM DEPOSITS OF APPARENT ORGANIC MATERIAL ON AND BETWEEN COIL WRAPS THROUGHOUT THE LENGTH OF THE SPECIMEN DEVICE. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. ALL JOINTS APPEAR TO BE CORRECT AND TACT BY VISUAL EXAMINATION AND BY NONDESTRUCTIVE TESTING. EXCEPT WERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE DAMAGE PRESENT AT THE DISTAL TIP, COMBINED WITH THE NATURE OF THE CORE WIRE FRACTURE SUGGESTS THE DEVICE CAME UNDER CONSTRAINT DURING THE CLINICAL APPLICATION AND WAS MANIPULATED IN SOME MANNER TO FREE THE DEVICE FROM THE CONSTRAINT CONDITION. THIS CONJECTURE IS SUPPORTED BY THE EXTENSIVE STRETCH DAMAGE AND THE NUMEROUS BENDS PRESENT OVER THE LENGTH OF THE SPECIMEN AND THEREFORE THE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENTERAL GUIDEWIRE WAS USED IN A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE TWO WALLFLEX COLONIC STENTS FAILED TO DEPLOY IN A STRICTURE IN THE SIGMOID COLON. IT IS UNKNOWN IF THE STRICTURE WAS MALIGNANT, BUT THE ANATOMY WAS NOT TORTUOUS. WHEN THE GUIDEWIRE WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE GUIDEWIRE WAS FRAYED. IT WAS REPORTED THAT NO PART OF THE GUIDEWIRE DETACHED. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION HAS BEEN DESCRIBED AS "FINE." ON (B)(6) 2011, INVESTIGATION RESULTS REVEALED A CORE WIRE FRACTURE, MAKING THIS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT SUPERSTIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MARLBOROUGH H965180011

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WALLFLEX ENTERNAL COLONIC STENT