BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2061632 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01157
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE MAVERICK 2 MONORAIL (MR) BALLOON CATHETER WAS RETURNED IN THE PRODUCT HOOP ALONG WITH THE PRODUCT SHELF CARTON, THE STOPCOCK WAS RECEIVED ATTACHED TO THE HUB. THERE WAS CONTRAST IN THE HUB AND WIRE LUMEN. INSPECTION OF THE BALLOON REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL MATERIAL MEASURING 14MM LONG. THE TEAR STARTED ABOVE THE PROXIMAL MARKERBAND AND EXTENDED MOST OF THE LENGTH OF THE BALLOON. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. THE REPORTED BALLOON BURST WAS CONFIRMED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 99% STENOSED, DENOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). A 3.0X15MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PREDILATION. THE BALLOON WAS INFLATED FOUR TIMES UNDER THE RATED BURST PRESSURE WITH A MAXIMUM PRESSURE OF 14ATMS. UPON THE FIFTH INFLATION TO 12ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 99% STENOSED, DENOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). A 3.0X15MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PREDILATION. THE BALLOON WAS INFLATED FOUR TIMES UNDER THE RATED BURST PRESSURE WITH A MAXIMUM PRESSURE OF 14ATMS. UPON THE FIFTH INFLATION TO 12ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892815300 13815560

    Patients

    Seq Age Sex Outcome Treatment
    1