BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1193281 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02918
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THE MANUFACTURING RECORDS FOR THIS BATCH 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 IS CONSIDERED OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT THE REPORTED EVENT IS ATTRIBUTABLE TO PROCEDURAL FACTORS AND/OR INTERACTION WITH PT ANATOMY OR OTHER DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. FOLLOWING A NON BSC STENT IMPLANTATION, FOR POST STENTING, A 3.0 X 15 MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS USED. ON THE FIRST INFLATION THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PT STATUS IS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X3.0 MM 11678319

    Patients

    Seq Age Sex Outcome Treatment
    1 GW: NEO'S ROUTE| INTRODUCER SHEATH: MEDIKIT 6F| INFLATION DEVICE: GETZ| STENT: CYPHER 23-3.0MM| GC: AXESS JR4