BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 3702695 · Received February 27, 2014

    Report

    Report Number
    3003862657-2014-00001
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    November 19, 2013
    Report Date
    January 2, 2014
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: REVIEW OF CASE SUMMARY PROVIDED BY THE HOSPITAL; NO COMPLAINT SAMPLE RETURNED FOR EVALUATION; NO CASE IMAGES, VIDEOS, ETC. WERE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED TO REX FOR REVIEW. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION PERFORMED FOR THIS LOT NUMBER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT FAILURE WAS DUE TO PHYSICIAN ERROR. CONCLUSION: THERE WAS NO COMPLAINT SAMPLE AVAILABLE FOR RETURN TO REX FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THE COMPLAINT PRODUCT IN QUESTION. A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT FAILURE WAS DUE TO PHYSICIAN ERROR - IMPROPER ATTACHMENT OF THE FILTER CARTRIDGE TO THE FILTER DELIVERY SHEATH. THIS PRODUCT COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PER THE FIELD COMPLAINT FORM: PHYSICIAN AT A (B)(6) HOSPITAL PLACED AN OPTION 6.5FR IVC FILTER UPSIDE DOWN IN THE IVC (PER THE TECHNICIAN IN IR). FILTER WAS REMOVED FROM THE PATIENT, THE FOLLOWING DAY. PHYSICIAN AND TECHNICIAN INADVERTENTLY PLACED CARTRIDGE IN WRONG DIRECTION ONTO DELIVERY SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122613 OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM INFERIOR VENA CAVA FILTER DTK REX MEDICAL, L.P. 352506070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention