BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 INDEFLATOR INFLATION DEVICE

    MDR report key: 4103471 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06082
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE USING A 20/30 INDEFLATOR AFTER STENT IMPLANTATION, IT WAS NOTED THAT THE HANDLE DETACHED FROM THE LOCKING MECHANISM DURING THE FIRST BALLOON DEFLATION. THE INDEFLATOR WAS CHANGED TO A DIFFERENT 20/30 INDEFLATOR AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. THE STENT BALLOON WAS SUCCESSFULLY DEFLATED WITHOUT ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585258 20/30 INDEFLATOR INFLATION DEVICE ACCESSORY KIT MAV AV-TEMECULA-CT 4042404

    Patients

    Seq Age Sex Outcome Treatment
    1