BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER

    MDR report key: 1935906 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05599
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 13, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K953602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL AND TACTILE EXAMINATION REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS NOT FOLDED OR WRAPPED AROUND THE SHAFT OF THE DEVICE. THERE WERE TRACES OF DRIED BLOOD VISIBLE INSIDE THE BALLOON. THE DEVICE WAS THEN ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) WHEN A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE BALLOON NOTED A CIRCUMFERENTIAL TEAR HAD OCCURRED IN THE BALLOON MATERIAL 5MM PROXIMAL TO THE TIP OF THE DEVICE. 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 (B)(6) REPORT. BASED ON ANALYSIS COMPLETED ON (B)(6) 2010 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 SHUNT OF A NON CALCIFIED AND MODERATELY TORTUOUS BRACHIUM VESSEL. AFTER THE GUIDEWIRE CROSSED THE LESION THE (B)(4) BALLOON WAS INSERTED AND INFLATED. ON THE FIRST INFLATION THE BALLOON RUPTURED AT TEN ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. DEVICE ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001103340 13705562

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MEDIKIT 5F| GUIDE WIRE: RADIFOCUS 0.035 INCH