BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3222452 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04925
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED A COMPLETE BALLOON DETACHMENT. THE BALLOON WAS NOT RETURNED. THE BALLOON HAD DETACHED FROM THE DISTAL AND PROXIMAL BALLOON BONDS. THE DEVICE DID NOT SHOW ANY SIGNS OF USE WITHIN THE PATIENT. THERE WAS NO DAMAGE TO THE REMAINING SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED (B)(4) 2013. IT WAS REPORTED THAT DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, CUTTING BALLOON RUPTURE OCCURRED. ACCESS WAS GAINED USING A 6F NON-BSC INTRODUCER SHEATH AT THE LEFT SIDE ELBOW VEIN. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT OF THE MODERATELY TORTUOUS AND CALCIFIED LEFT SIDE FOREARM VEIN. A NON-BSC 0.014" GUIDEWIRE WAS THEN SELECTED AND ADVANCED TO CROSS THE LESION. A 4 MM X 1.5 CM X 140 CM SPCB FLEXTOME MR CUTTING BALLOON WAS THEN SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, UPON INFLATION AT 8 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AT 12 ATM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, ADDITIONAL INFORMATION REVEALED BALLOON DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322592 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15735527

    Patients

    Seq Age Sex Outcome Treatment
    1 0.014" CRUISE GUIDEWIRE| EVEREST INFLATION DEVICE| 6F TERUMO SHEATH