BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2243486 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03791
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED FOR ANALYSIS IN TWO SECTIONS AS A RESULT OF A BREAK THAT WAS PRESENT IN THE HYPOTUBE. THE BREAK WAS LOCATED 16CM DISTAL TO THE STRAIN RELIEF. A DETAILED EXAMINATION OF THE BREAK SITE IDENTIFIED THAT THE BREAK OCCURRED AS A RESULT OF A SEVERE KINK THAT DEVELOPED IN THE HYPOTUBE. IT IS NOTED THAT BOTH SECTIONS OF THE BROKEN HYPOTUBE WERE KINKED AT VARIOUS LOCATIONS ALONG THEIR LENGTHS. BOTH THE BREAK AND THE KINKS THAT WERE IDENTIFIED ALONG THE SHAFT ARE CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. NO ISSUES WERE NOTED WITH THE PROFILE OF THE BALLOON AND TIP SECTIONS OF THE DEVICE. 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 BASE ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PLAIN OLD BALLOON ANGIOPLASTY PROCEDURE, A CATHETER SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED TARGET WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00MMX20MM APEX MONORAIL BALLOON CATHETER WAS SELECTED FOR PREDILATION. WHILE ADVANCING THE BALLOON CATHETER THROUGH A SAPHENOUS VEIN GRAFT TO THE RCA, THE PHYSICIAN APPLIED FORCE, THE CATHETER KINKED AND SNAPPED IN HALF. THE BREAK OCCURRED OUTSIDE OF THE GUIDE CATHETER APPROXIMATELY 14CM FROM THE PROXIMAL HUB OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS CURRENTLY DOING FINE. HOWEVER, RETURN DEVICE ANALYSIS REVEALED THE BREAK WAS LOCATED 16CM DISTAL TO THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895920300 14281365

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR