BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 770894 · Received August 16, 2006

    Report

    Report Number
    6000093-2006-01534
    Event Type
    Malfunction
    Date Received
    August 16, 2006
    Date of Event
    June 29, 2006
    Report Date
    July 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS COULD NOT VERIFY THE DIFFICULTY STATE IN THE COMPLAINT. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS RECEIVED IN GOOD CONDITION WITH NO DAMAGE OBSERVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE DID NOT REVEAL ANY DEFECTS OR DAMAGE TO THE DEVICE THAT WOULD HAVE CONTRIBUTED TO THE BALLOON LEAK DIFFICULTIES. THE CATHETER WAS PURGED COMPLETELY OF AIR AND THE BALLOON WAS INFLATED WITH WATER TO ITS RATED BURST PRESSURE. THE CATHETER WAS PRESSURIZED WITHOUT SIGNIFICANT LOSS OF PRESSURE. WHEN THE CATHETER WAS SUBJECTED TO A VACUUM, THE BALLOON DEFLATED NORMALLY AND THERE WAS NO COMPROMISE OF THE GENERATED VACUUM. THE CAUSE OF THE DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7852136 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. NO PROBLEM WAS FOUND WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A POBA PROCEDURE, THE MAVERICK2 MONORAIL BALLOON LEAKED AND A PINHOLE WAS NOTED DURING PREPARATION. THE LESION TO BE TREATED IS UNK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER PTCA CATHETER LOX BOSTON SCIENTIFIC 20MM X 3.0MM 7852136

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR