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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

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B.BRAUN MEDICAL SAS VENATECH CONVERTIBLE VENA CAVA FILTER Back to Search Results
Model Number 5010028
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2018
Event Type  Malfunction  
Manufacturer Narrative

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 (9612452-2018-00038). This batch has been sold since may 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. -one filter leg is in a horizontal position. Another leg is slightly distorted. -the patient is correctly protected against pe. These x-rays do not allow us to determine the origin of the resistance encountered during the filter release. However the filter seems to have been pushed to be released while the ifu specify to withdraw the sheath towards yourself. Conclusion: the elements received do not allow us to determine why a resistance was encountered during filter progression inside the sheath. The review of the films confirms that one filter legs is crossed. The complaint rate for this type of incident is inferior to 0. 2%. No corrective action is envisaged. This seems to demonstrate that the filter was pushed to be released while the ifu request to hold the pusher in one hand, take the sheath in the other hand and under fluoroscopy, draw the sheath towards yourself. This movement deploys the filter. Remember: to ensure proper filter positioning, it is extremely important to not move the pusher: -after the filter is positioned for deployment. - during filter deployment. 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. B braun medical (b)(4) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation.

 
Event Description

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. Physician noted that it felt like it was stuck on something in the sheath.

 
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Brand NameVENATECH CONVERTIBLE
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
26 rue armengaud
saint cloud 92210
FR 92210
Manufacturer (Section G)
B.BRAUN MEDICAL SAS
avenue des temps modernes
chasseneuil du poitou 86361
FR 86361
Manufacturer Contact
catherine boismenu
30, avenue des temps modernes
chasseneuil du poitou, 86361
FR   86361
MDR Report Key7855320
MDR Text Key120244584
Report Number9612452-2018-00037
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5010028
Device Catalogue Number5010028
Device LOT Number36908328
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/07/2018 Patient Sequence Number: 1
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