BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENATECH CONVERTIBLE

    MDR report key: 7167707 · Received January 5, 2018

    Report

    Report Number
    9612452-2018-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    November 27, 2017
    Report Date
    January 3, 2017
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    K152765. NOTE: PRODUCT REFERENCE 4435140 IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE 5010028 CLEARED UNDER #510K152765. BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH THE SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED DURING PRODUCTION. NO OTHER COMPLAINT HAS BEEN REPORTED ON THIS VENA CAVA FILTER BATCH SOLD SINCE APRIL 2017. 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 FEMORAL APPROACH. THE UPPER PORTION OF THE FILTER IS CORRECTLY DEPLOYED BUT THE FILTER FEET REMAIN CONSTRAINED (NON OPENED). NO FILTER MIGRATION THREAT. THE INTERVENTION WITH THE BALLOON ALLOWED COMPLETE OPENING OF THE FILTER. THIS PROVES THAT IT IS NOT A RIGID OBJECT NEITHER FILTER ENTANGLING WHICH COULD EXPLAIN THIS PARTIAL FILTER OPENING. THE PATIENT IS CORRECTLY PROTECTED AGAINST PE. AN UNUSED DEVICE FROM THE SAME BATCH HAS BEEN EVALUATED. IT COMPLIES WITH OUR SPECIFICATIONS. NO MANUFACTURING DEFECT WAS OBSERVED ON THE COMPLETE DEVICE. CONCLUSION: THE ELEMENTS RECEIVED DO NOT ALLOW US TO DETERMINE WHY THE FILTER DID NOT COMPLETELY OPEN AFTER RELEASE. THE REVIEW OF THE FILMS CONFIRMS THE FILTER WAS CORRECTLY DEPLOYED AFTER THE REINTERVENTION. THIS IS AN ISOLATED CASE. NO CORRECTIVE ACTION IS ENVISAGED. B BRAUN MEDICAL (B)(4) 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

    "THE FEMALE PATIENT WAS HOSPITALIZED DUE TO VENOUS THROMBOSIS OF LOWER EXTREMITY. FOR PROPHYLAXIS OF PULMONARY EMBOLISM, SHE RECEIVED OPERATION TO IMPLANT VENA CAVA FILTER ON (B)(6) 2017. DURING OPERATION, 8 ARMS OF THE FILTER COULD NOT OPENED AS NORMAL. THE FILTER WAS LIKE AN UMBRELLA POINTING DOWNWARDS WHICH COULD NOT FUNCTIONING TO HOLD VENOUS THROMBOSIS. TREATMENT: PIGTAIL CATHETER WAS USED TO HELP EXPAND THE FILTER ARMS BUT FAILED. THE OPERATOR PUSHED A BALLOON CATHETER FORWARD AND PASSED THROUGH THE BODY OF FILTER. THEN INFLATED THE BALLOON TO EXPAND FILTER ARMS. AFTER INTERVENTION, THE FILTER WAS ALMOST OPENED. IMAGE SHOWED THAT THE ENDS OF 2 ARMS STILL STICKED TOGETHER AND WAS NOT FULLY RELEASED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13460 VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM DTK B.BRAUN MEDICAL SAS 4435140 36919397

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention