BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK INDEFLATOR

    MDR report key: 12196607 · Received July 20, 2021

    Report

    Report Number
    2024168-2021-06209
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 25, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAV
    UDI-DI
    08717648013973
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED MATERIAL SEPARATION WAS ABLE TO BE CONFIRMED. THE REPORTED LEAK WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT IS POSSIBLE THAT INADVERTENT MISHANDLING DURING SHIPMENT AND/OR DURING PREPARATION FOR USE RESULTED IN COMPROMISING THE INDEFLATOR SUCH THAT DURING INFLATION RESULTED IN THE REPORTED/NOTED FACEPLATE AND GAUGE SEPARATION/BREAKS AND SUBSEQUENTLY RESULTED IN THE REPORTED LEAK; HOWEVER THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED/NOTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. D4 - PART NUMBER UPDATED FROM 1003327 TO 1000184.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL INDEFLATOR REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX LESION. THE FIRST INDEFLATOR THE PRESSURE GAUGE WOULD NOT GO UP TO REFLECT THE ATMOSPHERES ACCURATELY OR AT ALL AFTER MULTIPLE ATTEMPTS THEREFORE, A LEAK WAS SUSPECTED. THE SECOND INDEFLATOR METER BROKE OFF/SPLIT OPEN IN TWO PIECES AT 16 ATMOSPHERES. IT ALSO TOOK A LONG TIME FOR THE BALLOON TO INFLATE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094821 20/30 PRIORITY PACK INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR 1003327 60276096 08717648013973

    Patients

    Seq Age Sex Outcome Treatment
    1