BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENATECH CONVERTIBLE FILTER

    MDR report key: 10906179 · Received November 25, 2020

    Report

    Report Number
    9612452-2020-00043
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 24, 2020
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04027478130752
    PMA / PMN Number
    K152765
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BATCH HISTORY REVIEW IS NOT POSSIBLE BECAUSE NEITHER BATCH NUMBER IS UNKNOWN. THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION; THE FILTER IS STILL IMPLANTED IN THE PATIENT'S BODY. A X-RAYS PICTURE WAS FORWARDED FOR ANALYSIS. IT SHOWS TWO DISTORTED STABILIZERS BUT IT DOES NOT ALLOW US TO DETERMINE THE ORIGIN OF THE INCORRECT FILTER DEPLOYMENT. CONCLUSION: THE ELEMENTS RECEIVED DO NOT ALLOW US TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. THERE IS NO UPWARD TREND ON SIMILAR INCIDENTS. NO CORRECTIVE ACTION IS ENVISAGED. B BRAUN MEDICAL SAS HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Description of Event or Problem · 1

    UPON PLACEMENT, THE FILTER DID NOT OPEN AND ONE LEG IS EXTENDING OUTSIDE THE FILTER PROFILE. PRE-PLACEMENT CAVOGRAM IS NOT AVAILABLE FOR REVIEW. THE FINAL FILM TAKEN AFTER IMPLANTATION IS AVAILABLE. THE INDICATION FOR FILTER IMPLANTATION IS UNKNOWN. THE APPROACH WAS JUGULAR. THE DIAMETER OF THE VENA CAVA BEFORE IMPLANTATION IS UNKNOWN. A SECOND FILTER WAS NOT USED TO COMPLETE THE PROCEDURE. PHYSICIAN REPORTS THAT THE PATIENT IS VERY ILL AND THE ACCOUNT DOES NOT EXPECT ANY FURTHER INTERVENTION REGARDING THIS FILTER. THERE WAS NO PRESSURE FELT OR CATCHING OF THE HOOKS IN THE DISTAL PORTION OF THE SHEATH. VERY FLAT IVC AND THE FELLOW DEPLOYED IT PROBABLY BY PUSHING IT FORWARD, SO IT CAUGHT ON THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371116 VENATECH CONVERTIBLE FILTER VENA CAVA FILTER SYSTEM DTK B.BRAUN MEDICAL SAS 5010028 04027478130752

    Patients

    Seq Age Sex Outcome Treatment
    1 Other