BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2040163 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-01273
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    November 26, 2010
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED AN UNRAVELED TIP. VISUAL INSPECTION OF THE RETURNED WIRE REVEALED IT WAS SEVERELY ELONGATED AND UNRAVELED. THE TEFLON COATING WAS SCRAPED OFF IN SEVERAL AREAS OF THE DEVICE. A CORE WIRE FRACTURE WAS NOTED 180CM FROM THE PROXIMAL END, WHERE THE CORE WIRE IS JOINED WITH THE BALL WELD. SEM ANALYSIS REVEALED THE FRACTURE SURFACE SHOWS A ZONE WITH AXIAL DIMPLE RUPTURE, CHARACTERISTIC OF A DUCTILE MATERIAL; ALSO THE WIRE IN A FAILURE ZONE PRESENTS A REDUCTION OF THE DIAMETER AS A RESULT OF AN ELONGATION MOTION, FRACTURE PRESENTS SOME SMEARED MATERIALS. NO MATERIAL ANOMALIES WERE FOUND. FRACTURE WAS DUE TO A TENSION OVERLOAD. 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 ADDITIONAL INFORMATION RECEIVED ON (B)(4), 2011. IT WAS REPORTED THAT DURING PREPARATION FOR A BILIARY STENT AND DRAIN INSERTION TREATMENT PROCEDURE, THE GUIDE WIRE BECAME UNRAVELED. THE TARGET LESION WAS LOCATED IN THE LIVER. THE HOOP WAS FLUSHED WITH SALINE AND WHILE ATTEMPTING TO REMOVE THE AMPLATZ SUPER STIFF GUIDE WIRE, IT BECAME STRETCHED AND UNRAVELED. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A FRACTURE IN THE DISTAL END OF THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465250 13685085

    Patients

    Seq Age Sex Outcome Treatment
    1