BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1022480 · Received March 31, 2008

    Report

    Report Number
    2134265-2008-00927
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MFG RECORDS FOR THIS BATCH HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORD'S REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE FOR THIS COMPLAINT IS DETERMINED TO BE OPERATIONAL CONTEXT. THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MFG SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE PERFORMANCE WAS LIMITED. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 15 MM X 1.5 MM MAVERICK2 MONORAIL BALLOON RUPTURED AT 12 ATMS. THE TOTAL NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNK. THE DEVICE WAS USED FOR APPROX FIVE MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "GOOD".

    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 / 1.5 11307282

    Patients

    Seq Age Sex Outcome Treatment
    1