BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2223289 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03505
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 AN ANGIOPLASTY TREATMENT PROCEDURE A SHAFT FRACTURE OCCURRED. THE DE NOVO CONCENTRIC LESION WAS LOCATED IN A MILD TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS 10MM AND THE DIAMETER WAS 2.5MM IN SIZE. THE PHYSICIAN ATTEMPTED TO PERFORMED THE KISSING BALLOON TECHNIQUE WITH THE NC QUANTUM APEX MR 15MM X 3.00MM BALLOON. HOWEVER, THE HYPOTUBE OF THE BALLOON BROKE BEFORE THE BALLOON WAS INFLATED. THE DISTAL SEGMENT OF THE BALLOON CATHETER WAS IN THE ABDOMINAL AORTA. THE DEVICE WAS REMOVED WITH A NON-BSC GUIDE LOOP CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415300 14366482

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention