BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK INDEFLATOR

    MDR report key: 13653832 · Received March 2, 2022

    Report

    Report Number
    2024168-2022-02141
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 7, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAV
    UDI-DI
    08717648013591
    PMA / PMN Number
    K961471
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    ON FEB 25TH, 2022 ABBOTT VASCULAR DECIDED TO INITIATE A VOLUNTARY FIELD ACTION FOR THIS PRODUCT. ABBOTT VASCULAR SUBMITTED MEDWATCH # 2024168-2022-01831 ON MARCH 4, 2022 WITH NOTIFICATION OF THE VOLUNTARY RECALL IN H7, (REMEDIAL ACTION INITIATED). CORRECTIVE ACTION HAS BEEN INITIATED PER SITE OPERATING PROCEDURES. FIELD SAFETY CORRECTIVE ACTION IS REQUIRED FOR SPECIFIC LOTS OF 20/30 AND PLUS 30 INDEFLATORS AND ASSOCIATED PRIORITY PACKS: 20/30 PRIORITY PACK WITH COPILOT, 20/30 PRIORITY PACK, PRIORITY PACK 20/30 W/115 RHV, PPAK 20/30 WITH RHV, PLUS 30, PPAKPLUS30, PPAKPLUS30 W/115 RHV. THIS ACTION IS BEING TAKEN DUE TO AN INCREASE IN THE COMPLAINT TREND FOR REPORTED LEAK/SPLASH AND LOOSE OR INTERMITTENT CONNECTION. 20/30 INDEFLATORS ARE AT AN INCREASED RISK OF LEAKING DUE TO A GAP IN THE HOSE SNAP FITTING. STOPCOCKS ARE AT AN INCREASED RISK OF LEAKING DUE TO A HIGHER TENDENCY FOR LOOSE CONNECTIONS WHEN NOT CONNECTED PROPERLY.NA

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ONE NONCONFORMING MATERIAL RECORD/EXCEPTION WAS GENERATED FOR THE FINISHED GOOD LOT TO INVESTIGATE THE REPORTED ISSUE IN ACCORDANCE WITH INTERNAL OPERATING PROCEDURES. A REVIEW OF THE COMPLAINT HISTORY REVEALED NO OTHER INCIDENTS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A CORONARY PROCEDURE WAS PERFORMED. THE INDEFLATOR (1000184, 60331727) WAS UNABLE TO HOLD PRESSURE AND A LEAK WAS SUSPECTED. THE STOPCOCK THAT COMES IN THE PPAK HAD NOT BEEN USED. A DELAY HAD OCCURRED; HOWEVER, THIS DELAY WAS NOT CLINICALLY SIGNIFICANT. THERE WAS NO ADVERSE PATIENT EFFECT, AND ANOTHER DEVICE WAS USED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293555 20/30 PRIORITY PACK INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR 1000184 60331727 08717648013591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown