BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1951341 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05892
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Report Date
    December 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT A BREAK HAD OCCURRED IN THE MIDSHAFT AT THE PORT SITE. THE DISTAL SECTION OF THE BREAK, INCLUDING THE BALLOON AND TIP, WERE NOT RETURNED FOR ANALYSIS. AN EXAMINATION OF THE BREAK SITE FOUND THAT THE EXTRUSION WAS STRETCHED AND THERE WAS A LONGITUDINAL TEAR IN THE EXTRUSION AT THE BREAK SITE. THE HYPOTUBE WAS SEVERELY KINKED AND COILED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, PROCESS, AND ASSEMBLY SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE USER RELATED. THE DEVICE WAS USED IN A LEG VESSEL AND THE DFU STATES THE DEVICE "THE COMPLAINT STATES THAT THE PHYSICIAN WAS USING THIS DEVICE IN THE LEG. THE DFU STATES THAT THE DEVICE IS "INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION."

    Description of Event or Problem · 1

    EVENT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING AN INTERVENTIONAL TREATMENT PROGRAM, A BALLOON CATHETER WAS UNABLE TO CROSS A LESION AND THE SHAFT WAS DAMAGED. THE LESION WAS LOCATED IN THE MODERATELY TORTUOUS LOWER EXTREMITY VESSEL. LESION DETAILS ARE UNKNOWN. THE APEX MONORAIL BALLOON 20MM X 3.00MM WAS ADVANCED THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON CATHETER ADVANCED WITH RESISTANCE, AND THEN REMOVED. THE SHAFT OF THE DEVICE WAS "CRUMBLED IN TWO OR THREE PLACES." THE BALLOON WAS "ACCORDIANED AND FLAT OR SMASHED", AND THE CATHETER WAS FLATTENED AND KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER PRODUCT ANALYSIS REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895920300 13736841

    Patients

    Seq Age Sex Outcome Treatment
    1