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

Model Number	5010024
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
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: "while attempting to place a venatech lp when the device deployed from the catheter the filter never opened.It ended up unopened in the patient's right atrium.After many attempts we successfully retrieved the device without any known harm to our patient.".

• Brand Name: VENA TECH
• Common Device Name: FILTER, INTRAVASCULAR, CAR
• Manufacturer (Section D): B. BRAUN MEDICAL; 30 avenue des temps modernes; chasseneuil-du-poitou vienne, 86360 ; FR 86360
• MDR Report Key: 15251464
• Report Number: 3006332832-2022-00001
• Device Sequence Number: 5808352
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: (01)04038653918164
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/18/2022

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: 08/25/2026
• Device Model Number: 5010024
• Device Catalogue Number: 5010024
• Device Lot Number: 36983912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2022
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown