BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3923660 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03951
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON AND BLOOD IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WERE MULTIPLE KINKS THROUGHOUT THE HYPOTUBE. THE DISTAL TIP WAS DAMAGED. MICROSCOPIC EXAMINATION OF THE BALLOON AND SHAFT REVEALED A 17MM LONGITUDINAL TEAR FROM THE PROXIMAL TO THE DISTAL ENDS OF THE BALLOON. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE OR THE REPORTED CROSSING DIFFICULTY. 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

    REPORTABLE BASED ON DEVICE ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT A CROSSING DIFFICULTIES WAS ENCOUNTERED AND SHAFT KINK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.50MM X 15MM EMERGE¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. SUBSEQUENTLY, IT WAS NOTED THAT THE CATHETER SHAFT WAS KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399561 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315350 16460920

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR