BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3202459 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04607
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE EMERGE CATHETER WAS RECEIVED WITH A COMPLETE SEPARATION OF THE HYPOTUBE. THE DISTAL PORTION OF THE EMERGE CATHETER WAS RECEIVED WITH A NON-BSC GUIDEWIRE INSIDE THE WIRE LUMEN WHICH WAS INSIDE THE LUMEN OF THE RELATED RUNWAY GUIDE CATHETER. THE GUIDEWIRE AND DISTAL PORTION OF THE EMERGE CATHETER WERE REMOVED FROM THE RUNWAY GUIDE CATHETER WITH NO UNUSUAL RESISTANCE. THE BALLOON WAS TIGHTLY FOLDED AND THERE WAS NO INDICATION THE BALLOON WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THE HYPOTUBE SEPARATION WAS 55CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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 DURING A LEFT HEART CATHETERIZATION PROCEDURE, A SHAFT BREAK OCCURRED, THE UNSPECIFIED TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS TO BE USED TO DILATE THE LESION; HOWEVER, THEY FELT RESISTANCE WHEN THEY WERE TRYING TO ADVANCE THE BALLOON THROUGH THE GUIDE CATHETER. THEY STOPPED AND PULLED THE BALLOON BACK BUT ONLY PART OF THE BALLOON CAME OUT, WHICH IS THE SHAFT. WHEN THEY REALIZED THAT THE BALLOON CATHETER WAS FRACTURED, THEY PULLED THE GUIDE CATHETER, THE WIRE AND EVERYTHING OUT OF THE BODY AND WENT BACK IN WITH A NEW GUIDE CATHETER, NEW WIRE AND A NEW BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302090 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918912200 15828220

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: RUNWAY 6F VL 3.5