BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETCH®2

    MDR report key: 4993345 · Received August 11, 2015

    Report

    Report Number
    2134265-2015-05389
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    July 13, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K101354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED ONE KINK ON THE CATHETER SHAFT AT THE STRAIN RELIEF. THE CATHETER SHAFT WAS BROKEN APPROXIMATELY 58CM FROM THE DISTAL TIP OF THE CATHETER. INSIDE DIAMETER OF PROXIMAL OF THE SHAFT WAS INSPECTED USING A .045 GAUGE PIN AND THE RESULT WAS THAT PROXIMAL SHAFT WAS IN SPECIFICATION. THE CATHETER WAS NOT FUNCTIONALLY TESTED DUE TO THE DAMAGE ON THE CATHETER SHAFT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHAFT BROKE. AFTER REMOVAL OF THIS FETCH®2 CATHETER, IT WAS NOTED THAT THE CATHETER WAS KINKED AND ALMOST BROKE APART WITH ONE METAL THREAD HOLDING IT TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WAS NO DIFFICULTY WITH IT DURING USE OR WITHDRAWAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHAFT BROKE. AFTER REMOVAL OF THIS FETCH2 CATHETER, IT WAS NOTED THAT THE CATHETER WAS KINKED AND ALMOST BROKE APART WITH ONE METAL THREAD HOLDING IT TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WAS NO DIFFICULTY WITH IT DURING USE OR WITHDRAWAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523777 FETCH®2 CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109400-001 0000186554

    Patients

    Seq Age Sex Outcome Treatment
    1