BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 4122400 · Received September 26, 2014

    Report

    Report Number
    2134265-2014-05837
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-05768. IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED. DURING PROCEDURE, AN 6F MACH1 GUIDE CATHETER WAS USED TO ENGAGE THE RIGHT CORONARY ARTERY. WHEN THE GUIDE CATHETER WAS TURNED, IT WAS NOTED THAT THE PROXIMAL PART OF THE GUIDE CATHETER WAS DETACHED. THE 6F MACH1 GUIDE CATHETER WAS THEN REMOVED AND WAS EXCHANGED WITH ANOTHER 6F MACH1 GUIDE CATHETER TO COMPLETE THE PROCEDURE. HOWEVER, IT WAS NOTED THAT THE SECOND GUIDE CATHETER WAS ALSO DETACHED AT THE PROXIMAL PART. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600898 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74934356190 0050815599

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR