BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1841485 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04461
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. A BREAK WAS NOTED IN THE HYPOTUBE AT 23.4CM DISTAL TO THE STRAIN RELIEF. BOTH SECTIONS OF THE BREAK WERE HELD TOGETHER BY THE OUTER SHEATH ON THE HYPOTUBE. AN EXAMINATION OF THE BALLOON FOUND NO ISSUES. THE BALLOON DID NOT APPEAR TO HAVE BEEN INFLATED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6)-2010: IT WAS REPORTED THAT WHILE REMOVING THE DEVICE FROM THE PACKAGING PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, A SHAFT KINK WAS NOTED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AS THE PHYSICIAN REMOVED THE 8MM X 1.50MM APEX FLEX MONORAIL BALLOON CATHETER FROM THE PACKAGING IT WAS NOTED THAT THE HYPOTUBE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493896108150 13209297

    Patients

    Seq Age Sex Outcome Treatment
    1