BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1935539 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05651
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 7, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A VISUAL EXAMINATION OF THE BALLOON DID NOT IDENTIFY ANY TEARS IN THE BALLOON MATERIAL. HOWEVER, WHEN THE DEVICE WAS INFLATED WITH AN ENCORE DEVICE A PINHOLE LEAK WAS IDENTIFIED IN THE BALLOON OVER THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBAND DID NOT IDENTIFY ANY ANOMALIES 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.0X15MM APEX BALLOON TO THE LESION TO PREDILATE AND INFLATED THE BALLOON TO 8ATMS AND THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0X15MM APEX BALLOON. NO COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE DE NOVO LESION WAS 70% STENOTIC AND LOCATED IN THE MILDLY TORTUOUS MID LAD. THE BALLOON RUPTURED AS SOON AS IT REACHED 8ATMS ON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A 2.75X24MM PROMUS ELEMENT WHICH WAS POST DILATED WITH A 3.0X15MM QUANTUM APEX BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915200 13778748

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW GUIDE WIRE| 6F TERUMO INTRODUCER SHEATH| ENCORE26 INFLATION DEVICE