BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON¿

    MDR report key: 2943630 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00668
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A VISUAL EXAMINATION IDENTIFIED THAT APPROXIMATELY 6 MM OF 1 BLADE AND PAD WAS LIFTED FROM THE PROXIMAL EDGE. THE BLADE WAS NOT DETACHING FROM THE BALLOON. A SECTION OF THE PAD REMAINED ON THE BALLOON AT THE PROXIMAL END. ALL REMAINING BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT/ POSITIVE PRESSURE WAS APPLIED WHEN A LEAK WAS NOTED. A FURTHER MICROSCOPIC EXAMINATION IDENTIFIED A LEAK ADJACENT TO THE LIFTED BLADE AT THE POINT WHERE IT WAS STILL BONDED TO THE BALLOON. THE TIP OF THE DEVICE WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY TREATMENT PROCEDURE, A LIFTED ATHEROTOME/BLADE OCCURRED. THE LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA OF THE LEFT ARM AND SHOULDER. THE PHYSICIAN USED A SYRINGE TO INFLATE A 2 CM PERIPHERAL CUTTING BALLOON AND ON THE SECOND INFLATION THE BALLOON RUPTURED. UPON REMOVAL IT WAS OBSERVED THAT THE ATHEROTOME/BLADE WAS BENT AND LOOSE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48574 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001BP50720B0 0015161883

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR BSC 7 FR INTRODUCER SHEATH