BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 2587415 · Received May 24, 2012

    Report

    Report Number
    2134265-2012-03114
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2012-03122, 2134265-2012-03121, AND 2134265-2012-03120. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, WITHDRAWAL DIFFICULTIES AND A BREAK OCCURRED. ACCESS WAS OBTAINED THROUGH RADIAL ARTERY. THE AORTIC ROOT WAS LARGE SO THE PHYSICIAN STARTED THE CASE WITH A MACH 1 VL 3, IT WAS TOO SMALL SO IT WAS EXCHANGED FOR A MACH 1 VL 3.5 AND THEN TO A MACH 1 VL 4.0 AND THEN A MACH 1 VL 4.5. DURING REMOVAL OF THE 3.5, 4.0 AND 4.5 DEVICES THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THEM FROM THE SHEATH AT THE DISTAL 3MM PORTION (TIP). DURING REMOVAL OF THE 4.5 DEVICE, THE DEVICE GOT STUCK AND REQUIRED FORCE TO REMOVE IT. UPON REMOVAL A SMALL SHARD OF PLASTIC, APPROXIMATELY 3MM IN LENGTH, WAS OBSERVED ON THE WIRE AND HUB; THE PHYSICIAN DOESN'T KNOW IF IT CAME FROM THE SHEATH OR GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK497

    Patients

    Seq Age Sex Outcome Treatment
    1 MACH 1 VL4 GUIDE CATHETER| ARROW MEDICAL INTRODUCER SHEATH| MACH 1 VL3 GUIDE CATHETER| MACH 1 VL3.5 GUIDE CATHETER