BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENATECH CONVERTIBLE

    MDR report key: 7855324 · Received September 7, 2018

    Report

    Report Number
    9612452-2018-00038
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 6, 2018
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04027478130752
    PMA / PMN Number
    K152765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH THE SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED DURING PRODUCTION. ANOTHER SIMILAR COMPLAINT HAS BEEN REPORTED ON THE SAME VENA CAVA FILTER BATCH BY THE SAME REPORTER (9612452-2018-00037). THIS BATCH HAS BEEN SOLD SINCE (B)(6) 2016. INVESTIGATION: THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION; THE FILTER IS STILL IMPLANTED IN THE PATIENT'S BODY. THE RECEIVED XRAY PICTURES SHOW THAT : THE FILTER WAS PLACED VIA JUGULAR APPROACH. TWO FILTER LEGS ARE DISTORTED AND ARE IN AN HORIZONTAL POSITION. A HOOK ON ONE OF THESE LEGS IS OPEN. THIS PROVES THAT IT WAS PROBABLY STUCK INTO THE SHEATH DURING FILTER PROGRESSION. THIS COULD EXPLAIN THE SIGNIFICANT RESISTANCE MET BY THE PHYSICIAN AND THE LEG DISTORTION. CONCLUSION: THE X-RAY PICTURES SEEMS SHOWING THAT THE RESISTANCE MET DURING FILTER PROGRESSION IS DUE TO THE FACT THAT ON HOOK WAS STUCK INTO THE SHEATH. UNFORTUNATELY THE SHEATH WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS. THIS IS A RARE INCIDENT. 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

    SIGNIFICANT RESISTANCE UPON IMPLANTING OF FILTER, RESULT WAS LEG CROSSING FULLY. RESISTANCE MID TO DISTAL SHEATH WHILE GOING THROUGH MASS OF IVC. RESISTANCE FELT MORE SO THAN TYPICAL. ON (B)(6) 2018 - IN A FAX FROM THE ACCOUNT: THE FILTER WAS DEPLOYED BUT WAS DISTORTED. AT LEAST ONE LEG WAS OFFSET. INDICATION FOR IMPLANTATION: PULMONARY THROMBOEMBOLISM WHEN ANTICOAGULANTS ARE CONTRAINDICATED. THE APPROACH WAS JUGULAR. DIAMETER OF THE VENA CAVA BEFORE IMPLANTATION: 18MM. THE PATIENT DID NOT HAVE A CENTRAL VENOUS CATHETER PLACED BEFORE FILTER PLACEMENT. FILTER LOCATION: INFRA-RENAL. DEPLOYMENT LEVEL: L3. THE PATIENT HAS NOT UNDERGONE SURGERY SINCE THE FILTER PLACEMENT. PATIENT CO-MORBIDITIES: OVARIAN CANCER. TIMEFRAME OF EVENT: DURING IMPLANT. CIRCUMSTANCES UNDER WHICH THE PIR INCIDENT WAS DISCOVERED: IMMEDIATELY AFTER IMPLANTATION/DEPLOYMENT. PATIENT HAD NO SYMPTOMS. NO ADVERSE EVENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696053 VENATECH CONVERTIBLE VENA CAVA FILTER DTK B.BRAUN MEDICAL SAS 5010028 36908328 04027478130752

    Patients

    Seq Age Sex Outcome Treatment
    1 Other