BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON®

    MDR report key: 3102172 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03440
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED BLOOD WITHIN THE BALLOON AND INFLATION LUMEN. THIS IS EVIDENCE OF A DEVICE LEAK DURING THE PROCEDURE. THE BALLOON WAS TORN IN A CIRCUMFERENTIAL MANNER IN THE DISTAL CONE. THERE WERE NO ISSUES WITH THE TIP OR MARKERBANDS. KINKS WERE PRESENT AT VARIOUS LOCATIONS ALONG THE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH FORCES BEING APPLIED TO THE SHAFT DURING USE/HANDLING. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE ARTERIOVENOUS FISTULA. THE PHYSICIAN ADVANCED A 8.00MMX2.0CMX90CM PERIPHERAL CUTTING BALLOON CATHETER TO THE TARGET LESION. UPON THE THIRD INFLATION THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. RETURNED PRODUCT ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204559 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB8020900

    Patients

    Seq Age Sex Outcome Treatment
    1