BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDEFLATOR

    MDR report key: 18954073 · Received March 21, 2024

    Report

    Report Number
    2024168-2024-03600
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 2, 2024
    Report Date
    November 13, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE (HANDLE BECAME DISENGAGED FROM THE SYRINGE). DEVICE HISTORY RECORD (DHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED AN INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. 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. CORRECTIONS: D1 ¿ BRAND NAME: UPDATED. D3 ¿ NAME, ADDRESS 1, CITY, POSTAL CODE: UPDATED. G4 - PMA/510(K) #: UPDATED FROM K961471 TO K991102.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS DURING RETURN ANALYSIS THE DEVICE BECAME COMPROMISED (HANDLE BECAME DISENGAGED FROM THE SYRINGE). DEVICE HISTORY RECORD (DHR) AND CORRECTIVE AND PREVENTIVE 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. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED LEAK (INDEFLATOR LEAKED FROM THE SEAL IN THE INDEFLATOR WHEN PRESSURE WAS APPLIED) CANNOT BE DETERMINED. INADVERTENT MISHANDLING DURING SHIPMENT BACK FOR RETURN ANALYSIS POSSIBLY COMPROMISED THE DEVICE THUS RESULTING IN THE DAMAGE OCCURRED DURING RETURN ANALYSIS (HANDLE BECAME DISENGAGED FROM THE SYRINGE WHILE ATTEMPTING TO PRESSURIZE); HOWEVER THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED/NOTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 20/30 PRIORITY PACK INDEFLATOR LEAKED FROM THE SEAL IN THE INDEFLATOR WHEN PRESSURE WAS APPLIED. THE DEVICE WAS CONNECTED TO THE STOPCOCK WHICH COMES WITH THE INDEFLATOR. ANOTHER INDEFLATOR 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
    533221 INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR INC. 1000184 60418466 08717648013591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown