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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

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B.BRAUN MEDICAL SAS VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM Back to Search Results
Model Number 4435140
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2017
Event Type  Malfunction  
Manufacturer Narrative

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.

 
Event Description

"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. ".

 
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Brand NameVENATECH CONVERTIBLE
Type of DeviceVENA CAVA FILTER SYSTEM
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
204 avenue du marechal juin
boulogne, 92100
FR 92100
Manufacturer (Section G)
B.BRAUN MEDICAL SAS
avenue des temps modernes
chasseneuil, 86361
FR 86361
Manufacturer Contact
catherine boismenu
30, avenue des temps modernes
chasseneuil du poitou 86360
FR   86360
MDR Report Key7167707
MDR Text Key97590327
Report Number9612452-2018-00001
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 01/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4435140
Device LOT Number36919397
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/05/2018 Patient Sequence Number: 1
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