BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDEFLATOR

    MDR report key: 20821106 · Received December 2, 2024

    Report

    Report Number
    2024168-2024-14107
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 1, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAV
    PMA / PMN Number
    K991102
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED AN INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A PRODUCTION RECORD REVIEW AND A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. ON (B)(6) 2024, ABBOTT VASCULAR DETERMINED THAT A FIELD ACTION WAS REQUIRED FOR SPECIFIC LOTS OF PPAK 20/30 W/COPILOT PRODUCT. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT IS FROM THE IMPACTED POPULATION. THIS ACTION IS BEING TAKEN DUE TO AN INCREASED POTENTIAL FOR A LEAK IN THE INDEFLATOR UNDER PRESSURE OR VACUUM DUE TO A GAP IN THE HOSE SNAP FITTING AND O-RINGS FROM A SPECIFIC SUPPLIER. CORRECTIONS: D4 - MODEL #/D4 - CATALOG # UPDATED FROM UNK INDEFLATOR 20/20 TO: 1003327. D4 - PRIMARY UDI NUMBER UPDATED FROM UNKNOWN TO: (B)(4). D4- A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. ON OCT 24TH 2024, ABBOTT VASCULAR DETERMINED THAT A FIELD ACTION WAS REQUIRED FOR SPECIFIC LOTS OF INDEFLATOR 20/20 PRODUCT. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT IS FROM THE IMPACTED POPULATION. B3: DATE OF PROCEDURE ESTIMATED AS 11/1/2024. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE TO TREAT AN UNKNOWN VESSEL AN INDEFLATOR WAS NOTED TO BE LEAKING DURING THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304943 INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR INC. 1003327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown