BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDEFLATOR

    MDR report key: 20555891 · Received October 29, 2024

    Report

    Report Number
    2024168-2024-12656
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 27, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAV
    UDI-DI
    08717648013973
    PMA / PMN Number
    K991102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. IT IS POSSIBLE THAT THE CONNECTION PORT WAS NOT FULLY CONNECTED/TIGHTENED AND/OR THE DEVICE BEING CONNECTED WAS COMPROMISED THUS RESULTING IN THE REPORTED LEAK DIFFICULTIES; HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED LEAK DIFFICULTIES. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. ADDITIONALLY, 4 STERILE/UNUSED DEVICES WERE RECEIVED WITH PART#1003327 AND LOT#60514710. A VISUAL AND FUNCTIONAL TEST WAS PERFORMED ON ALL 4 DEVICES. NO DAMAGE OR ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). TWO 20/30 INDEFLATORS WERE USED TO INFLATE A BALLOON; HOWEVER, DURING INFLATION, THE INDEFLATORS WERE NOTED TO NOT HOLD PRESSURE AND BUBBLES WERE SEEN FLOATING BACK INTO THE INDEFLATOR. BOTH INDEFLATORS WERE REMOVED AND ANOTHER ABBOTT DEVICE WAS USED TO 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
    302466 INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR INC. 1003327 60514710 08717648013973

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male