BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    MDR report key: 4988428 · Received August 5, 2015

    Report

    Report Number
    2027111-2015-00498
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 4, 2015
    Report Date
    December 16, 2016
    Manufacturer
    APPLIED MEDICAL
    Product Code
    EYB
    PMA / PMN Number
    K921838
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING ATTEMPTED TO INFLATE BALLOON, TO CHECK FOR LEAKAGE; HOWEVER, THE BALLOON COULD NOT BE INFLATED DUE TO IT BEING BLOCKED. AFTER REMOVING THE BLOCKAGE, ENGINEERING ATTEMPTED TO RE-INFLATE THE BALLOON, BUT FOUND THE BALLOON WAS RUPTURED. THE LEAKAGE MAY BE ATTRIBUTED TO HIGH THERMAL ACTIVITY OF THE CUTTING WIRE, WHICH RESULTED IN THE BALLOON RUPTURING AND CAUSING IT TO BE UNABLE TO REMAIN INFLATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THIS LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. THE HAZARD ANALYSIS FOR THIS DEVICE WAS REVIEWED AND IT WAS DETERMINED THAT THE RISK LEVELS REMAIN UNCHANGED AND ACCEPTABLE. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    ENDOPYELOTOMY PROCEDURE - "DR. (B)(6) WAS PERFORMING THE PROCEDURE AND THE BALLOON WOULD NOT DILATE DURING APPLICATION. TERRITORY MANAGER (B)(6) WAS PRESENT DURING THE PROCEDURE AND CAREFULLY OBSERVED DR. (B)(6) FOR THE INSTRUCTION. THE BALLOON DILATED FOR APPROXIMATELY 2 SEC AND FAILED. (B)(6) ALSO SPOKE WITH THE PHYSICIAN IMMEDIATELY AFTER THE PROCEDURE. THE LARGER (OUTER) BOX LOT NUMBER IS 1241965." INTERVENTION - "NA". PATIENT STATUS - "NA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519114 B1005, ACUCISE ENDOPYELOTOMY SYSTEM EYB APPLIED MEDICAL B1005 1233689

    Patients

    Seq Age Sex Outcome Treatment
    1