BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE MAX 20 BALLOON DILATATION CATHETER

    MDR report key: 2000430 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00449
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K972357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS NO DAMAGE NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED FULLY AROUND THE SHAFT OF THE DEVICE. THERE WERE SOME TRACES OF BLOOD VISIBLE ON THE BALLOON. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) WHEN A LEAK WAS NOTED IN THE BALLOON MATERIAL. MICROSCOPIC EXAMINATION OF THE BALLOON OBSERVED A 1MM CIRCUMFERENTIAL TEAR LOCATED 7MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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

    ORIGINALLY THIS WAS TO BE REPORTED ON THE 1ST QUARTER ALTERNATIVE SUMMARY REPORT. BASED ON ANALYSIS COMPLETED ON (B)(6) 2011 THIS WILL NOW BE REPORTED AS AN INDIVIDUAL MDR. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE BMQ/4-4/5.8/75 BALLOON WAS INFLATED AND RUPTURED AT TEN ATMOSPHERES. IT IS UNKNOWN HOW MANY INFLATIONS OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD. RETURNED DEVICE ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE MAX 20 BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001125070 11472572

    Patients

    Seq Age Sex Outcome Treatment
    1