BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1033539 · Received April 24, 2008

    Report

    Report Number
    2134265-2008-01196
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    February 20, 2008
    Report Date
    April 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT COULD POTENTIALLY BE RELATED TO THE COMPLAINT INCIDENT. VISUAL EXAMINATION OF THE RETURNED DEVICE, FOUND THAT THE BALLOON WAS PARTIALLY INFLATED WITH SOLIDIFIED CONTRAST MEDIA. AN EXAMINATION OF THE SHAFT, PROXIMAL TO THE BALLOON, FOUND THAT IT WAS BUNCHED UP FROM APPROXIMATELY 1 MM PROXIMAL TO THE PROXIMAL TRANSITION OF THE BALLOON AND THIS BUNCHING EXTENDED PROXIMALLY ALONG THE SHAFT FOR 7 MM IN TOTAL LENGTH. THE DAMAGE TO THE SHAFT IS CONSISTENT WITH EXCESSIVE FORCES HAVING BEEN APPLIED TO THE SHAFT. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON INFLATED TO ITS RATED BURST PRESSURE WITH NO RESTRICTIONS NOTED. A VACUUM WAS PULLED AND THE BALLOON DEFLATED SLOWER THAN PRODUCT SPECIFICATION. THE SLOW DEFLATION TIME IS CONSISTENT WITH THE BUNCHING THAT WAS PRESENT IN THE SHAFT. NO OTHER ISSUES EXISTED WITH THIS DEVICE. A MICROSCOPIC EXAMINATION OF THE PROXIMAL WELD AREA FOUND NO EVIDENCE OF FOCAL NECKING. TAKING INTO CONSIDERATION THE THOROUGH EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CORONARY ARTERY ANGIOPLASTY PROCEDURE, INFLATION DIFFICULTIES OCCURRED. THE 90% STENOSED, NON-CALCIFIED, TARGET LESION WAS IN THE MODERATELY TORTUOUS "HIGH LATERAL" (HL) ARTERY. A 2.5X15MM APEX MONORAIL BALLOON CATHETER WAS USED TO DILATE AN UNSPECIFIED AREA IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BALLOON WAS THEN ADVANCED TO THE HL. DURING THE 1ST INFLATION, THE BALLOON WAS DIFFICULT TO INFLATE IN THAT THE DEVICE "INFLATED SEVERAL SECONDS LATER" . A SECOND ATTEMPT TO INFLATE THE DEVICE FAILED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND AN ADDITIONAL ATTEMPT TO INFLATE THE DEVICE FAILED EVEN THOUGH THE GAUGE ON THE UNKNOWN TYPE INFLATION DEVICE "ROSE". THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X15MM APEX MONORAIL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD". HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THERE WAS SHAFT DAMAGE WITH DEFLATION DIFFICULTIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X15MM 11316907

    Patients

    Seq Age Sex Outcome Treatment
    1