MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BRAUN FILTER SYSTEM VENA CAVA CNVT J-F LOG 2124081; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	5010028
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Filter deployed in right atrium; the ivc filter was deployed using the plunger device in the kit but a hook of the filter hung on the sheath.While the sheath was removed from the inferior vena cava, the filter moved with the sheath and deployed in the right atrium fda safety report id# (b)(4).

• Brand Name: BRAUN FILTER SYSTEM VENA CAVA CNVT J-F LOG 2124081
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 10069742
• Report Number: MW5094541
• Device Sequence Number: 2899849
• Product Code: DTK
• UDI-Device Identifier: 04027478130752
• UDI-Public: 04027478130752
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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 Expiration Date: 04/21/2024
• Device Model Number: 5010028
• Device Catalogue Number: 5010028
• Device Lot Number: 36946554
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 87