MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS VENA TECH; FILTER, INTRAVASCULAR CAR

Catalog Number	5010024
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility: ivc fitter was inserted via rt.Jugular access.Once deployed struts did not open.Had to manipulate wires/ catheters to open fitters struts.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A review of the non-conformance system database was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: VENA TECH
• Common Device Name: FILTER, INTRAVASCULAR CAR
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; 30 avenue des temps modernes; chasseneuil-du-poitou, vienne 86360 ; FR 86360
• MDR Report Key: 19476860
• Report Number: 3006332832-2024-00002
• Device Sequence Number: 6932338
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: (01)04038653918164
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024
• Report Date (Section F): 10/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2026
• Device Catalogue Number: 5010024
• Device Lot Number: 36982159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2024
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/29/2024