BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 1024310 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00974
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 17, 2007
    Report Date
    March 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED A BALLOON TEAR. THE BALLOON CATHETER WAS RECEIVED IN GOOD CONDITION WITH NO DAMAGE OBSERVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A TEAR IN THE BALLOON WALL LOCATED 7 MILLIMETERS PROXIMAL TO 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 TEAR. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL OR WITH THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE TEAR. THE SHOP FLOOR PAPERWORK HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SHOP FLOOR PAPERWORK REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE WAS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    EVENT BECAME REPORTABLE BASED UPON INVESTIGATION COMPLETED ON 03/07/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, THE BALLOON FAILED TO INFLATE. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 8X3.0 MM QUANTUM MAVERICK MONORAIL BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 6 ATMS; HOWEVER, IT FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 8X3.0 MM 11284532

    Patients

    Seq Age Sex Outcome Treatment
    1