BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 839160 · Received April 17, 2007

    Report

    Report Number
    6000089-2007-00576
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Report Date
    April 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOUND THAT A BREAK HAD OCCURRED IN THE HYPOTUBE. THE BREAK WAS LOCATED APPROX 79 CM DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE DISTAL SECTION OF THE BREAK FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THERE WERE TRACES OF SOLIDIFIED BLOOD IN THE BALLOON AND INFLATION LUMEN. A DETAILED MICROSCOPIC EXAMINATION OF THE BREAK SITE FOUND THAT THE BREAK APPEARED TO HAVE OCCURRED AS A RESULT OF A SEVERE KINK THAT DEVELOPED IN THE HYPOTUBE. NO ISSUES WERE NOTED WITH THE ACTUAL DEVICE THAT COULD CAUSE THE BREAK TO OCCUR. A REVIEW OF THE MFR RECORD FOR BATCH 9022402 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PROD SPECS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE BREAK IS UNK.

    Description of Event or Problem · 1

    REPORTABILITY DECISION CHANGED BASED ON ANALYSIS COMPLETED 12APR2007. IT WAS INITIALLY REPORTED THAT THERE WAS A PROD COMPLAINT. NO FURTHER INFO WAS AVAILABLE. ANALYSIS FOUND A BREAK IN THE HYPOTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK 2 MONORAIL 15MM X 2.5 MM 0009022402

    Patients

    Seq Age Sex Outcome Treatment
    1 YR