BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3833683 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-02832
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER AND AN EMERGE SHELF BOX. THE BATCH NUMBER ON THE PACKAGING AND THE BATCH NUMBER OF THE DEVICE MATCHED THIS COMPLAINT. THE CATHETER WAS INSPECTED TACTILELY AND UNDER MAGNIFICATION. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN AND THE BALLOON WAS TIGHTLY WRAPPED. THE DISTAL TIP WAS DAMAGED. THERE WERE MULTIPLE HYPOTUBE KINKS AND THE HYPOTUBE WAS BROKEN 78.5CM FROM THE STRAIN RELIEF; THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THERE WAS NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED TO DILATE THE TARGET LESION. WHEN THE DEVICE WAS BEING ADVANCED THROUGH A NON-BSC GUIDE CATHETER, IT WAS NOTED THAT THE BALLOON CATHETER "SNAPPED". THE SHAFT BROKE 60 CENTIMETERS FROM THE HUB . THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED TO DILATE THE TARGET LESION. WHEN THE DEVICE WAS BEING ADVANCED THROUGH A NON-BSC GUIDE CATHETER, IT WAS NOTED THAT THE BALLOON CATHETER "SNAPPED." THE SHAFT BROKE 60 CENTIMETERS FROM THE HUB . THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310467 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918912350 16049394

    Patients

    Seq Age Sex Outcome Treatment
    1