BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFROAD RE-ENTRY CATHETER SYSTEM

    MDR report key: 2810279 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06605
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A INTERVENTION PROCEDURE, A SHAFT FRACTURE OCCURRED. THE PHYSICIAN NOTED THAT DURING USE OF THE OFFROAD RE-ENTRY DEVICE THE MICROCATHETER LANCET BROKE WHILE ATTEMPTING TO CROSS A BIFURCATED VESSEL. THE MICROCATHETER WAS ADVANCED THREE TIMES IN THE PROCEDURE IN ORDER TO REPOSITION THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFROAD RE-ENTRY CATHETER SYSTEM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK723

    Patients

    Seq Age Sex Outcome Treatment
    1