BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1230446 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04261
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. BLOOD WAS PRESENT IN THE BALLOON AND DISTAL OUTER. THE SYSTEM WAS PRESSURIZED TO NOMINAL BURST PRESSURE (6ATM) IN THE PRODUCT ANALYSIS LAB TO LOCATE THE LEAK. A BALLOON WAS THEN INSPECTED UNDER MAGNIFICATION. A BALLOON PINHOLE WAS CONFIRMED IN THE BALLOON WALL LOCATED ABOVE THE PROXIMAL END OF THE PROXIMAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE PINHOLE DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE PINHOLE. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL AND WITH THE RO MA. THE MANUFACTURING RECORDS FOR THIS BATCH NUMBER HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    SAME CASE AS MFR. REPORT # 2134265-2008-04260. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, TWO BALLOON PINHOLE LEAKS OCCURRED. THE SEVERELY CALCIFIED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE MAVERICK2 15MM X 2.0MM BALLOON CATHETER WAS ADVANCED TO THE LESION, HOWEVER, UPON ATTEMPTING TO INFLATE THE BALLOON A PINHOLE LEAK WAS NOTED AT LESS THAN 1ATM OF PRESSURE. THE DEVICE WAS REMOVED AND A SECOND MAVERICK2 15MM X 2.0MM BALLOON CATHETER WAS ADVANCED, HOWEVER, THIS BALLOON ALSO CONTAINED A PINHOLE LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED A "FINE".

    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 MAVERICK2 15 /2.0 11777617

    Patients

    Seq Age Sex Outcome Treatment
    1