BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK INDEFLATOR

    MDR report key: 13524429 · Received February 14, 2022

    Report

    Report Number
    2024168-2022-01494
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 31, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAV
    UDI-DI
    08717648013973
    PMA / PMN Number
    K961471
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 TWO OTHER SIMILAR INCIDENTS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. ON FEBRUARY 25TH, 2022, ABBOTT VASCULAR DETERMINED THAT A 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 COPLIOT, 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 DEVICE CODE 1354, LEAK/SPLASH AND (RDC) 1371 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.

    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 COPLIOT, 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. THE INDEFLATOR WAS ATTEMPTED TO BE USED, HOWEVER, IT DIDN'T INFLATE THE BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049859 20/30 PRIORITY PACK INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR 1003327 60326298 08717648013973

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown