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

Model Number	31335
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other similar complaint was reported on this batch of vena cava filters.Investigation: despite requests, either precise information about the incident nor x-ray pictures are available for analysis.Consequently no thorough investigation can be performed.No conclusion can be drawn.This type of incident is known complication of the vena cava filter.Compared to the literature, the complaint rate for this type of incident with venatech lp is low and satisfactory.The benefits overweight the risks.No corrective action is currently 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 or Problem Description
Initial attempt at placing a venatech lp filter was complicated by the filter not opening up and deploying properly.This resulted in filter migration into the right ventricle and ultimately into the right lower lobe pulmonary artery.The filter never properly deployed.Ultimately, a decision was made to leave the filter as an intentional foreign body, as the risk of attempting to retrieve it outweighed the benefit.

• Brand Name: VENATECH LP
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 9604855
• Report Number: 9612452-2020-00003
• Device Sequence Number: 18969526
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 4038653918164
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 01/30/2024
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: 36943446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR