BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDEFLATOR

    MDR report key: 20953245 · Received December 17, 2024

    Report

    Report Number
    2024168-2024-14844
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 1, 2024
    Report Date
    February 6, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAV
    PMA / PMN Number
    K991102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. IT IS POSSIBLE THAT THE CAP SEAL WAS NOT FULLY TIGHTENED THUS RESULTING IN THE REPORTED LEAK DIFFICULTIES; HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED LEAK DIFFICULTIES CANNOT BE DETERMINED. 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. D4 CORRECTION: MODEL, CATALOG NUMBER FROM 1000186 TO 1003327. 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. B3: DATE OF PROCEDURE ESTIMATED TO (B)(6) 2024. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE PPAK 20/30 COPILOT IS FAILING IN CONTROLLING THE BLEEDBACK [LEAK]. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457496 INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR INC. 1003327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown