BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER

    MDR report key: 39233 · Received September 23, 1996

    Report

    Report Number
    1222632-1996-00009
    Event Type
    Injury
    Date Received
    September 23, 1996
    Date of Event
    August 1, 1996
    Report Date
    September 20, 1996
    Manufacturer
    NITINOL MEDICAL TECHNOLOGIES, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILTER HOUSING CRACKED WHEN ATTACHED TO THE INTRODUCER. T-ADAPTER SEPARATED BETWEEN POLYCARBONATE SLIP FIT AND VINYL BORST ADAPTER. REVIEW FOUND THAT THE LOT NUMBER FOR THE LUER LOCK RING WAS 47404-2. LOT NUMBER FOR THE CAP WAS 47406-2. THE ONLY DEVIATIONS FROM STANDARD ASSEMBLY PROCEDURES WAS THAT A WHITE HAZE APPEARED ON THE STORAGE TUBES AFTER STANDING OVERNIGHT ON THE FLOW BENCH. PARTS WERE REWORKED BY POLISHING THE EXTERIOR WITH A LINT-FREE WIPE. THIS DEVIATION IS NOT CONSIDERED TO BE A CONTRIBUTING CAUSE OF THIS COMPLAINT. MULTI-MATERIAL, MULTI-COMPONENT T-ADAPTER WAS REPLACED BY SINGLE COMPONENT Y-ADAPTER PER 510K # K950489, INSTITUTED IN 1995.

    Description of Event or Problem · 1

    THE FILTER HOUSING CRACKED WHILE BEING ATTACHED TO THE INTRODUCER. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER DELAY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER Implant VENA CAVA FILTER DTK NITINOL MEDICAL TECHNOLOGIES, INC. 2110F 13-054728

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening| R