BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT SUPERSTIFF GUIDEWIRE

    MDR report key: 2138296 · Received June 23, 2011

    Report

    Report Number
    3005099803-2011-02128
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    DQX
    PMA / PMN Number
    K760944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE CATHETER WAS STRETCHED TO A LENGTH OF APPROXIMATELY 519.4 CM FROM AN OVERALL LENGTH OF 500.55CM. THE SPECIMEN PRESENTS INDICATIONS TENSILE OVERLOAD OF THE CORE WIRE IN THE DISTAL PORTION. THE REGION IMMEDIATELY PROXIMAL OF THE CORE WIRE FRACTURE PRESENTS INDICATIONS OF BENDING OVERLOAD WITH SOME TORSIONAL LOADING. BOTH ASPECTS OF THE CORE WIRE FRACTURE PRESENT REDUCTIONS IN CROSS-SECTIONAL AREA CONSISTENT WITH A DUCTILE, TENSILE OVERLOAD FRACTURE. THE SPECIMEN ALSO PRESENTS SEVERAL BENDS / KINKS OVER THE DISTAL 42.5 CM OF THE CORE WIRE. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. ALL JOINTS APPEAR TO BE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY LION-DESTRUCTIVE TESTING. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE REPORT OF DAMAGE TO THE SPECIMEN DEVICE IS CONFIRMED. ATTEMPTS TO REPEATEDLY REPRODUCE THE FRACTURE CONDITION DURING WITHDRAWAL FROM THE DISPENSER UNDER CONTROLLED CONDITIONS HAVE BEEN UNSUCCESSFUL TO DATE. AT THIS TIME IT APPEARS HANDLING FACTORS IMPACTED ON THE EVENT AS REPORTED; ASSIGNMENT OF ROOT CAUSE IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT SUPER STIFF GUIDEWIRE WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PREPARATION FOR THE PROCEDURE IT WAS NOTED THAT THE COATING OF THE WIRE WAS PEELED. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE". THIS EVENT WAS MADE REPORTABLE BASED ON INVESTIGATION RESULTS THAT REVEALED THAT THE CORE WIRE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT SUPERSTIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MARLBOROUGH H965180011 0002416359

    Patients

    Seq Age Sex Outcome Treatment
    1