BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDEFLATOR

    MDR report key: 18792372 · Received February 27, 2024

    Report

    Report Number
    2024168-2024-02439
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 7, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAV
    UDI-DI
    08717648013591
    PMA / PMN Number
    K991102
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 20/30 PRIORITY PACK INDEFLATOR DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS ABLE 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 EIGHT OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. SUBSEQUENT TO FILING THE INITIAL REPORTS, 49 STERILE UNUSED DEVICES WERE RECEIVED WITH LOT NUMBER 60418468. A VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED. 26 STERILE UNUSED UNITS WERE RANDOMLY SELECTED. ALL 26 SAMPLES WERE VISUALLY INSPECTED WITH NO ANOMALIES NOTED. ALL 26 SAMPLES UNDERWENT FUNCTIONAL TESTING AND 6 FAILED PRESSURIZATIONS. THE 6 STERILE UNUSED DEVICES WHICH FAILED PRESSURIZATION WILL BE FILED ON SEPARATE MDR REPORTS. ADDITIONAL INFORMATION: D4 - MODEL # ADDED CORRECTIONS: D1 - BRAND NAME UPDATED D2A - COMMON DEVICE NAME UPDATED D3 - NAME UPDATED D3 - ADDRESS, CITY, POSTAL CODE UPDATED CORRECTION: D4 - MODEL # UPDATED TO 1000184.

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # CORRECTION: CORRECTED FROM K961471 TO K991102. H11 CORRECTION: ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONALLY, A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON UNUSED/STERILE UNITS FROM THE SAME PART AND LOT NUMBER. ABNORMALITIES WERE FOUND. ON OCT 24TH 2024, ABBOTT VASCULAR DETERMINED THAT A FIELD ACTION WAS REQUIRED FOR SPECIFIC LOTS OF INDEFLATOR 20/30 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE, WHILE CONNECTED DIRECTLY TO THE BALLOON, IT WAS IMPOSSIBLE TO INFLATE THE BALLOON AS THE INDEFLATOR COULD NOT HOLD PRESSURE. TWO OTHER INDEFLATORS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME RESULT. A FOURTH INDEFLATOR FROM THE SAME LOT WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE, WHILE CONNECTED DIRECTLY TO THE BALLOON, IT WAS IMPOSSIBLE TO INFLATE THE BALLOON AS THE INDEFLATOR COULD NOT HOLD PRESSURE. TWO OTHER INDEFLATORS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME RESULT. A FOURTH INDEFLATOR FROM THE SAME LOT WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO HARM TO THE PATIENT. SUBSEQUENT TO THE INITIALLY FILED REPORT, SEVEN ADDITIONAL DEVICES WERE RECEIVED. ONE INDEFLATOR HAD THE FACE PLATE SEPARATED FROM THE HOUSING. ANOTHER HAD THE FACE PLATE SEPARATED AS WELL AS THE NEEDLE SEPARATED AND NOT RETURNED. THE ADDITIONAL RETURNED DEVICES WERE REPORTEDLY USED TO RUN ADDITIONAL TESTS BY THE OPERATING ROOM MEMBERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628525 INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR INC. 1000184 60418468 08717648013591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED BALLOON