BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3180233 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04514
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 27, 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 RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED IN TWO SECTIONS TO THE COMPLAINT INVESTIGATION SITE AS A RESULT OF A SHAFT BREAK LOCATED 25CM FROM THE CATHETER TIP. THERE WAS NO EVIDENCE OF BALLOON INFLATION. SLIGHT STRETCHING WAS EVIDENT AT THE BREAK SITE. NO KINKS OR DAMAGE WERE NOTED TO THE REMAINING SECTIONS OF THE DEVICE. A MICROSCOPIC EXAMINATION OF THE TIP, BALLOON, AND BLADES FOUND NO ISSUES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. 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 DEVICE ANALYSIS (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A CUTTING BALLOON RUPTURED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER PREDILATION, A 4.00 MM X 1.5 CM X 140 CM SPCB FLEXTOME MR CUTTING BALLOON CATHETER WAS THEN SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT AN UNKNOWN PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280279 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 0015543637

    Patients

    Seq Age Sex Outcome Treatment
    1