BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 956397 · Received April 26, 2007

    Report

    Report Number
    6000093-2007-00861
    Event Type
    Malfunction
    Date Received
    April 26, 2007
    Report Date
    March 28, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED A BALLOON TEAR IN THE CATHETER. THE BALLOON CATHETER WAS RECEIVED WITH THE BALLOON IN A DEFLATED STATE AND BLOOD WAS OBSERVED IN THE BALLOON AND THE INFLATION LUMEN. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A PIN HOLE TEAR IN THE BALLOON WALL LOCATED 1.2 CM PROXIMALLY FROM THE DISTAL TIP. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE TEAR. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL OR WITH THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE LEAK. DURING THE MFG PROCESS ALL UNITS ARE TESTED FOR BALLOON LEAKS. ALL DEVICES ARE PLACED IN INDIVIDUAL VALIDATED PACKAGING SPECIFICALLY DESIGNED TO ACCOMMODATE THE SHAPE OF THE DEVICE IN ORDER TO PROTECT THEM DURING THE SHIPMENT PROCESS. THE EXACT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 9233988 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    COMPLAINT DETERMINED TO BE REPORTABLE BASED ON ANALYSIS APPROVED 28 MARCH 2007. IT WAS REPORTED THAT DURING A PTCA PROCEDURE THE MAVERICK2 MONORAIL BALLOON WOULD NOT INFLATE. THE CATHETER WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME CATHETER. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "OKAY." ANALYSIS REVEALED A PIN HOLE TEAR IN THE BALLOON WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,PERCUTANEOU LOX BOSTON SCIENTIFIC MAVERICK2 15/2.0 9233988

    Patients

    Seq Age Sex Outcome Treatment
    1 *