BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 2941023 · Received February 4, 2013

    Report

    Report Number
    2134265-2013-00735
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AVAIL MEDICAL PRODUCTS INCORPORATED
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING PREPARATION OF A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE BAG OF A GUIDE CATHETER WAS OPENED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 90CM MODEL-6F PV MACH1 MP GUIDE CATHETER WAS SELECTED TO BE ADVANCED INTO THE TARGET LESION. UPON PREPARATION OF THE DEVICE, IT WAS NOTED THAT THE BAG WAS ALREADY OPENED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46916 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY AVAIL MEDICAL PRODUCTS INCORPORATED M001196260 0050611675

    Patients

    Seq Age Sex Outcome Treatment
    1