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

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.".

• Brand Name: VENATECH CONVERTIBLE
• Type of Device: VENA 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 Key: 7167707
• MDR Text Key: 97590327
• Report Number: 9612452-2018-00001
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• 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 Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: 4435140
• Device Lot Number: 36919397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR