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

Catalog Number	5010024
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: filter did not fully deploy at the time of implant and has since "opened" up more to about 50% they can't return it, it's still in the patient.The patient is most likely going to a different hospital to have it removed.

• Brand Name: VENA TECH
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; 30 avenue des temps modernes; chasseneuil-du-poitou, vienne 86360 ; FR 86360
• MDR Report Key: 25233105
• Report Number: 3006332832-2026-00007
• Device Sequence Number: 21391934
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: (01)04038653918164(11)221114(17)271114(10)37003363
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026
• Report Date (Section F): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5010024
• Device Lot Number: 37003363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2026
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2026