BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 3053058 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02222
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: RECEIVED PRODUCT CONSISTED OF AN EMERGE MONORAIL (MR) BALLOON CATHETER RECEIVED WITH BLOOD IN THE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED, WHICH IS CONSISTENT OF HAVING POSITIVE PRESSURE APPLIED. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE ADJACENT WITH THE PROXIMAL END OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE PINHOLE. THERE WAS ALSO TIP DAMAGE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. 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 ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A CATHETER WAS UNABLE TO CROSS THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE 2.0 X 15MM EMERGE MR BALLOON CATHETER WAS ADVANCED THROUGH A NON BSC GUIDE CATHETER, AND OVER A NON BSC GUIDE WIRE, BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156736 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315200 15646284

    Patients

    Seq Age Sex Outcome Treatment
    1 J & J BRITE TIP: GUIDE CATHETER| ASAHI INTECC RINATO: GUIDE WIRE