BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE GUIDEWIRE

    MDR report key: 1910186 · Received November 30, 2010

    Report

    Report Number
    2134265-2010-05297
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    August 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K011968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETURNED DEVICE REVEALED A DISTAL WIRE SHAFT FRACTURE. THE DEVICE PRESENTS INDICATIONS OF A TENSILE OVERLOAD OF THE FLATTENED, GROUND DISTAL REGION OF THE WIRE SHAFT 3.81CM DISTAL OF THE PROXIMAL COIL TO WIRE SHAFT SOLDER JOINT, NORMALLY CONCEALED BY THE DISTAL COIL. THE WIRE SHAFT HAS SUSTAINED BENDS/KINKS AT 0.32CM, 0.50 TO 3.45CM, AND 32.3 TO 32.8CM FROM THE PROXIMAL ASPECT OF THE WIRE FRACTURE. THE DISTAL COIL IS STRETCHED AN INDETERMINATE LENGTH BEGINNING 2.60CM FROM THE DISTAL TIP AND EXTENDING TO THE DISTAL LIMIT OF THE PROXIMAL COIL TO WIRE SHAFT SOLDER JOINT. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE DEVICE. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6), 2010 IT WAS REPORTED THAT DURING UNPACKING, REMOVAL DIFFICULTIES OCCURRED. AFTER THE PHYSICIAN 'RELEASED THE END', PUSHED THE 300CM FORTE GUIDE WIRE FORWARD AND PUSHED THE TIP OF THE DEVICE OUT OF THE HOOP SLIGHT RESISTANCE WAS NOTED. THE PHYSICIAN THEN PULLED THE FORTE GUIDE WIRE FORWARD. ONCE THE WIRE WAS REMOVED FROM THE HOOP IT WAS NOTED THAT THE WIRE WAS 'THIN AND STRAIGHTENED'. THE WIRE WAS NOT USED DURING THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN. DEVICE ANALYSIS REVEALED A GUIDE WIRE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H7493494910J0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR