BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT - BALLOON CATHETER

    MDR report key: 2931498 · Received January 28, 2013

    Report

    Report Number
    2954740-2013-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 4, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    MJN
    PMA / PMN Number
    K080861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING PREP, THE BALLOON (BRS00060900/ C11024) INFLATED BUT WOULD NOT DEFLATE. THE PREP WAS PER LABELING INSTRUCTIONS AND THE CASE WAS FINISHED WITHOUT ANY OTHER PROBLEMS. THE CONCENTRATION USED TO INFLATE THE BALLOON WAS 50/50, AND THE BALLOON WAS INFLATED PER IFU WITH NORMAL PRESSURE. THE BALLOON WAS INFLATED WITH A 5CC SYRINGE. NO KINKS, COMPRESSIONS, OR BENDS ON THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. AS RECEIVED, THE UNIT WAS CORRECTLY BAGGED AND SEALED. ALTHOUGH IT WAS NOT IN THE HUB CLIP, NO DEFECT WAS NOTICED ON THE OUTER SURFACE. HOWEVER, DRY CONTRAST MEDIA WAS FOUND ALONG THE INFLATION LUMEN OF THE CATHETER AS WELL AS INSIDE THE BALLOON INFLATION PORT. CATHETER FLUSHED APPROPRIATELY. HOWEVER, THE BALLOON COULD NOT BE INFLATED. EVEN THOUGH THE DRY CONTRAST COULD BE REMOVED FROM THE INFLATION LUMEN PORT, THE INFLATION TEST COULD NOT BE PERFORMED. CONTRAST CRYSTAL FORMATION INSIDE THE BALLOON CATHETER LUMEN DID NOT ALLOW THE BALLOON INFLATION/DEFLATION TEST. INFLATION CROSS SECTIONAL AREA IS OBSTRUCTED. THE ROOT CAUSE OF THIS PRODUCT COMPLAINT COULD NOT BE DETERMINED SINCE THE BALLOON INFLATION/DEFLATION TEST COULD NOT BE PERFORMED. ALL POSSIBLE CAUSES IDENTIFIED AS PARTS OF THIS PRODUCT COMPLAINT ARE DISCARDED BECAUSE OF THE BALLOON INFLATION/DEFLATION TEST COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THE FAILURE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED, SINCE DRY CONTRAST IMPEDED TESTING OF THE BALLOON. PROCEDURAL FACTORS COULD HAVE CONTRIBUTED TO THE FAILURES REPORTED, BUT NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING PREP, THE BALLOON (B)(4) INFLATED BUT WOULD NOT DEFLATE. THE PREP WAS PER LABELING INSTRUCTIONS AND THE CASE WAS FINISHED WITHOUT ANY OTHER PROBLEMS. THE CONCENTRATION USED TO INFLATE THE BALLOON WAS 50/50, AND THE BALLOON WAS INFLATED PER IFU WITH NORMAL PRESSURE. THE BALLOON WAS INFLATED WITH A 5CC SYRINGE. NO KINKS, COMPRESSIONS, OR BENDS ON THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37558 ASCENT - BALLOON CATHETER CES BALLOON CATHETER MJN MICRUS ENDOVASCULAR, LLC NA C11024

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 5CC SYRINGE.