BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 3050525 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02321
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE SPECIMEN PRESENTS INDICATIONS OF SEVERAL INCIDENTS OF COLUMN OVERLOAD AND PROLAPSE MANIFESTED BY THE VARIOUS BENDS/KINKS OF VARYING SEVERITY SCATTERED OVER THE LENGTH OF THE SPECIMEN. THE SPECIMEN ALSO PRESENTS APPROXIMATELY 1.15MM OF THE CORE WIRE PROTRUDING THROUGH THE OUTER COIL WRAPS APPROXIMATELY 2.05CM FROM THE DISTAL TIP WITH A CONCURRENT OFFSET COIL CONDITION AT THE CORE WIRE PENETRATION. DRIED BLOOD-LIKE MATERIAL DEPOSITS ARE PRESENT ON AND BETWEEN THE COIL WRAPS THROUGHOUT THE LENGTH OF THE SPECIMEN. APPARENT TISSUE DEPOSITS ARE ADHERED TO THE DISTAL 2.1CM OF THE SPECIMEN. THE SPECIMEN PRESENTS NO INDICATION OF FRACTURE. THE J-FORM TAIL ANGLE IS RELAXED TO APPROXIMATELY 140O. FUNCTION IS COMPROMISED BY THE DAMAGE TO THE SPECIMEN AND THE DEPOSITS OF DRIED BLOOD-LIKE MATERIAL. 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 NON-DESTRUCTIVE TESTING. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE A GUIDEWIRE FRACTURE OCCURRED. DURING THE ANGIOPLASTY PROCEDURE, THE STARTER GUIDEWIRE "HAS DONE A LOOP ON ITSELF AND BROKE." THE PHYSICIAN MANAGED TO REMOVE THE BROKEN DEVICE. THE PROCEDURE WAS STOPPED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. THE PATIENT'S STATUS WAS REPORTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE A GUIDEWIRE FRACTURE OCCURRED. DURING THE ANGIOPLASTY PROCEDURE, THE STARTER GUIDEWIRE "HAS DONE A LOOP ON ITSELF AND BROKE." THE PHYSICIAN MANAGED TO REMOVE THE BROKEN DEVICE. THE PROCEDURE WAS STOPPED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. THE PATIENT'S STATUS WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152405 STARTER GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001491181 0010188632

    Patients

    Seq Age Sex Outcome Treatment
    1