BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1882610 · Received October 26, 2010

    Report

    Report Number
    2134265-2010-04738
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THE DEVICE WAS ATTACHED TO AN INFLATION UNIT AND A PINHOLE LEAK WAS NOTED OVER THE DISTAL EDGE OF THE DISTAL MARKERBAND. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND DISTAL MARKERBAND COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. DURING THE FIRST INFLATION WITH A 3.0 X 20MM APEX MONORAIL BALLOON CATHETER, THE BALLOON RUPTURED AT 6 ATMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT TYPE OF DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. DURING THE FIRST INFLATION WITH A 3.0 X 20MM APEX MONORAIL BALLOON CATHETER, THE BALLOON RUPTURED AT 6 ATMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT TYPE OF DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895920300 13548711

    Patients

    Seq Age Sex Outcome Treatment
    1