BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK OTW PTCA CATHETER

    MDR report key: 689878 · Received August 5, 2005

    Report

    Report Number
    6000089-2005-01179
    Event Type
    Malfunction
    Date Received
    August 5, 2005
    Date of Event
    July 6, 2005
    Report Date
    July 11, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INITIALLY THOUGHT TO BE DISPOSED, BUT WAS RECENTLY RECEIVED FOR ANALYSIS; RETURNED DEVICE ANALYSIS: PRODUCT ANALYSIS COULD NOT VERIFY THE COMPLAINT. THE CATHETER WAS PURGED OF AIR AND THE BALLOON WAS INFLATED WITH WATER TO ITS RATED BURST PRESSURE. THE CATHETER WAS THEN 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 MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7251972 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. EACH CATHETER IS INFLATED TO ITS RATED BURST PRESSURE DURING THE MANUFACTURING LEAK TEST TO CHECK FOR CATHETER LEAKS. THE CAUSE OF THE DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A PTCA TREATMENT PROCEDURE, THE MAVERICK OTW 20/1.5 MM BALLOON RUPTURED AT UNKNOWN ATMS ON THE THIRD INFLATION. (THE NUMBER OF ATMS REACHED ON THE INITIAL TWO INFLATIONS WAS 6 ATMS). THE PATIENT WAS ASYMPTOMATIC DURING THIS EVENT. THE LESION BEING TREATED WAS A VERY CALCIFIED, 100% STENOTIC LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN USED A CONQUEST GUIDEWIRE AND A 8F MACH1 GUIDE CATHETER TO CROSS THE LESION. THE MAVERICK OTW BALLOOWN WAS REMOVED AND REPLACED WITH A CROSSSAIL 1.5/15 MM BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS 'FINE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OTW PTCA CATHETER PTCA CATHETER LOX BOSTON SCIENTIFIC MAV-OTW 20/1.5MM 7251972

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN