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

Device Problem Insufficient Information (3190)

Patient Problem Great Vessel Perforation (2152)

Event Date 07/11/2018

Event Type  Injury  

Event Description

Filter was implanted into patient on or about (b)(6) 2015.On (b)(6) 2018, patient underwent a computerized tomography scan ("ct scan") of the abdomen.Examination of the ct scan by a qualified expert radiologist revealed that the ivc filter is malpositioned with struts perforating through the wall of the ivc.

• Type of Device: VENATECH FILTER
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; 26 rue armengaud; saint-cloud, 92210 ; FR 92210
• MDR Report Key: 12246425
• MDR Text Key: 264095954
• Report Number: 3006332832-2021-00005
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/29/2021,07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Distributor Facility Aware Date: 07/15/2021
• Date Report to Manufacturer: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability