BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 925965 · Received March 29, 2007

    Report

    Report Number
    6000093-2007-00680
    Event Type
    Malfunction
    Date Received
    March 29, 2007
    Date of Event
    March 12, 2007
    Report Date
    March 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    DEVICE EVALUATION: PRODUCT ANALYSIS VERIFIED THE DIFFICULTY AS STATED IN THE COMPLAINT. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS RECEIVED IN GOOD CONDITION WITH NO DAMAGE OBSERVED. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A PINHOLE TEAR IN THE BALLOON WALL LOCATED 1.9 CENTIMETERS PROXIMALLY FROM THE DISTAL TIP. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL AND WITH THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE LEAK. THERE ARE A NUMBER OF FACTORS THAT MAY INFLUENCE A COMPLAINT OF THIS NATURE, THESE INCLUDED THE STENOSIS AND CALCIFICATION LEVELS, THE LEVELS OF TORTUOSITY OF THE VESSEL OR IF THE LESION WAS PRE-DILATED. THE EXACT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE MFG RECORDS FOR BATCH 9210625 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE PHYSICIAN DID AN ABRASION WITH A ROTA AND THEN INFLATED THE QUANTUM MAVERICK MONORAIL BALLOON WHICH RUPTURED AT 18ATMS ON THE THIRD INFLATION. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOTIC LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2.5X8 QUANTUM MAVERICK BALLOON. PATIENT STATUS IS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BOSTON SCIENTIFIC CORPORATION 2.5X12 9210625

    Patients

    Seq Age Sex Outcome Treatment
    1 *