BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-SNARE

    MDR report key: 15933012 · Received December 7, 2022

    Report

    Report Number
    2032582-2022-00007
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    October 27, 2022
    Report Date
    December 7, 2022
    Manufacturer
    PFM MEDICAL MEPRO GMBH
    Product Code
    DXE
    PMA / PMN Number
    K011783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURER AND INVESTIGATED. THE MANUFACTURER CHECKED THE ASSOCIATED DOCUMENTS AND USED A SAMPLE OF THE SAME TYPE FOR A COMPARATIVE INVESTIGATION. THE ERROR CHARACTERISTIC COULD NOT BE DETERMINED AND THE DOCUMENTS DID NOT SHOW ANY ABNORMALITIES. ACCORDING TO THE DOCUMENTATION, ALL TESTS ON THE CLAIMED SAMPLE DURING PRODUCTION WERE CARRIED OUT IN CONFORMITY AND WERE CARRIED OUT IN CONFORMITY AND EVALUATED AS OK. WITHOUT THE COMPLAINT SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE PRODUCT DID NOT COMPLY WITH THE SPECIFICATION. THE COMPLAINT IS UNJUSTIFIED.

    Description of Event or Problem · 0

    A SNARE BROKE OFF IN A PATIENT WHILE COMPLETING A FILTER REMOVAL, THEY WERE ABLE TO FIND THE PIECE THAT BROKE OFF IN THE VESSEL SO NO FURTHER ACTION WAS REQUIRED. THE BROKEN SNARE WAS NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576668 MULTI-SNARE SNARE DXE PFM MEDICAL MEPRO GMBH 147315V2 1033591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other