BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 4217388 · Received October 9, 2014

    Report

    Report Number
    3003862657-2014-00007
    Event Type
    Other
    Date Received
    October 9, 2014
    Report Date
    July 30, 2014
    Manufacturer
    REX MEDICAL LP
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: REQUEST/REVIEW CASE IMAGES, VIDEOS, ETC. TO BE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED TO FOR EVALUATION. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR PRODUCT COMPLAINT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS PRODUCT COMPLAINT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFO PROVIDED TO REX MEDICAL FOR INVESTIGATION. THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION; THERE WERE NO CASE IMAGES OR VIDEOS PROVIDED FOR REVIEW. THERE WAS NO LOT NUMBER PROVIDED FOR THE PRODUCT COMPLAINT SO A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED TO CHECK FOR ANY MANUFACTURING ABNORMALITIES. THIS PRODUCT COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    AS REPORTED TO REX MEDICAL VIA ARGON PRODUCT EXPERIENCE REPORT FORM: DURING RETRIEVAL AFTER SHEATHING DOWN NOTICED ON LEG WAS OUTSIDE OF SHEATH. IT HAD FRACTURED AT SOME UNIDENTIFIED TIME. DURING RETRIEVAL OF THE LEG, IT FRACTURED AGAIN AND TWO SMALL PIECES COULD NOT BE RETRIEVED AS THEY WERE INCORPORATED INTO THE CAVA WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636926 OPTION ELITE RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL LP 352506070E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other