BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER

    MDR report key: 3810177 · Received May 1, 2014

    Report

    Report Number
    3003862657-2014-00005
    Event Type
    Other
    Date Received
    May 1, 2014
    Report Date
    April 5, 2014
    Manufacturer
    REX MEDICAL LP
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: REQUEST/REVIEW CASE IMAGES, VIDEOS, ETC. TO BE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVAL: COMPLAINT SAMPLE WAS NOT RETURNED TO FOR EVAL. RETAIN DEVICE EVAL: NO DEVICE RETAIN EVAL 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: (B)(6) AT (B)(6) WAS CONSULTED BY ANOTHER PHYSICIAN TO SEE IF AN MRI SCAN COULD BE SAFELY CONDUCTED ON A PT WITH AN IMPLANTED FRACTURED OPTION IVC FILTER. THE CONSULTING PHYSICIAN PROVIDED (B)(6) A LETTER FROM DR. (B)(6) AT (B)(6) STATING THAT THE PT HAD A FRACTURED OPTION IVC FILTER AND THAT THE FRACTURED COMPONENT WAS RETAINED INTRACORPOREALLY. (B)(6) CALLED ARGON CUSTOMER SERVICE TO INQUIRE ABOUT THE SAFETY OF CONDUCTING AN MRI SCAN ON THIS PT. (B)(6) QUESTION AND CONTACT INFO WAS FORWARDED TO ME. AFTER CONSULTING WITH REX MEDICAL, I FOLLOWED UP WITH (B)(6) TO INQUIRE ABOUT THE FRACTURED FILTER. (B)(6) DID NOT HAVE ANY MORE INFO THAN WHAT WAS INCLUDED IN THE LETTER. THAT INFO IS PROVIDED HERE. THE DEVICE IS NOT BEING RETURNED AS IT REMAINS IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261964 OPTION RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL LP 352506070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1