BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK INDEFLATOR

    MDR report key: 11695290 · Received April 20, 2021

    Report

    Report Number
    2024168-2021-03313
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAV
    UDI-DI
    08717648013591
    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 LEAK WAS UNABLE TO BE CONFIRMED. 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 IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. AS THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED DURING RETURN ANALYSIS, IT IS POSSIBLE THAT THE DEVICE WAS NOT FULLY CONNECTED RESULTING IN THE REPORTED LEAK; HOWEVER, THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED LEAK CANNOT BE DETERMINED. THE NOTED GAP ON THE FACEPLATE LIKELY OCCURRED DURING PACKAGING AND/OR DURING SHIPMENT FOR RETURN ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ADDITIONALLY, 7 STERILE/UNUSED INDEFLATORS WITH PART # 1000184 LOT # 60246772 WERE RETURNED FROM THE ACCOUNT. ALL 7 RETURNED DEVICES WERE VISUALLY INSPECTED AND THERE WAS NO DAMAGE NOTED TO ANY OF THE STERILE/UNUSED DEVICES. TESTING WAS SUCCESSFULLY PERFORMED ON THE STERILE/UNUSED DEVICES WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 20/30 INDEFLATOR WAS NOTED TO HAVE BUBBLING CONTINUALLY INDICATING AN AIR LEAK. ANOTHER 20/30 INDEFLATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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
    594423 20/30 PRIORITY PACK INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR 1000184 60246772 08717648013591

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR