BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY¿

    MDR report key: 3012103 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01460
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 19, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS NOT FULLY FOLDED OR WRAPPED AROUND THE SHAFT OF THE DEVICE AND THE TIP WAS INSIDE THE BALLOON. IN ADDITION, THE TIP WAS NOTED TO BE SLIGHTLY CURVED INSIDE THE BALLOON. SOLIDIFIED CONTRAST MEDIA WAS PRESENT INSIDE THE BALLOON. DURING ANALYSIS, THE BALLOON WAS UNABLE TO BE INFLATED DUE TO THE SOLIDIFIED CONTRAST MEDIA. THE DEVICE WAS SOAKED OVERNIGHT IN A WATERBATH. THE DEVICE WAS AGAIN ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE OF 15 ATMOSPHERES. THE INFLATION DEVICE WAS VERIFIED AT 15 ATMOSPHERES BEFORE AND AFTER USE WITH A CALIBRATED PRESSURE GAUGE. HOWEVER, A LEAK WAS NOTED COMING FROM THE DISTAL TIP OF THE DEVICE. THERE WERE NO LEAKS NOTED IN THE BALLOON. ON MICROSCOPIC EXAMINATION OF THE DISTAL TIP, IT WAS CONFIRMED THAT THE DISTAL BOND HAD PARTIALLY DETACHED AND THE DISTAL SLEEVE WAS TURNED INSIDE OUT. THERE WAS EVIDENCE OF UV GLUE CURED ON THE TIP. ON CLOSER EXAMINATION OF THE BALLOON SLEEVE IT WAS DETERMINED THAT THERE WAS ROUGHENING PRESENT. EXAMINATION OF THE TIP USING DYE HIGHLIGHTED AN IMPRESSION OF WHERE THE SLEEVE WAS BONDED INDICATING THAT THE SLEEVE WAS ROUGHENED OR HAS SOME LEVELS OR ROUGHEN PRESENT. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    ORIGINALLY THIS WAS REPORTED ON (B)(4) 2012 ALTERNATIVE SUMMARY REPORT. BASED UPON ANALYSIS COMPLETED ON (B)(4) 2013 THIS WILL NOW BE REPORTED AS AN INDIVIDUAL MDR. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS ANTEBRACHIAL ARTERIO VENOUS GRAFT SHUNT VEIN. INFLATION WAS PERFORMED FIVE TIMES AT FIFTEEN ATMOSPHERES WITH THE SV/5.5-4/4T/90 BALLOON CATHETER. ON THE FIFTH INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. DEVICE ANALYSIS REVEALED THE BALLOON BOND HAD DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115640 SYMMETRY¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001103860 15414686

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MOSQUITO 5F| GUIDE WIRE: KYOUSHA| INFLATION DEVICE: ENCORE26