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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 08/07/2018
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 (9612452-2018-00037). 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.

 
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. 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.

 
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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 Key7855324
MDR Text Key119943673
Report Number9612452-2018-00038
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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