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

Model Number	5010024
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: a review of the manufacturing records shows the involved batch of filters complied with specifications.No other similar complaints were reported to the manufacturer for this lot of vena cava filters, sold since july 2021.Investigation: neither device nor the x-ray pictures are not available for evaluation.Conclusion: with the elements at our disposal, the exact root cause of what held the filter closed cannot be found.Our records show that the involved batch has been manufactured according to our specifications and requirements.No other similar complaint was reported on this filters batch.The complaint rate for this type of incident with venatech lp vena cava filter is low (0,01%).No corrective action is currently envisaged.
Event or Problem Description
Ivc fitter was inserted via rt.Jugular access.Once deploued struts did not open.Had to manipulate wires/ catheters to open fitters struts.
Additional Manufacturer Narrative
Correction: initial medwatch :" b.4.Date of this report": 04/14/2024.It was an error.The correct "date of this report" is : 06/17/2024.
Event or Problem Description
Ivc fitter was inserted via rt.Jugular access.Once deploued struts did not open.Had to manipulate wires/ catheters to open fitters struts.

• Brand Name: VENATECH LP
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• MDR Report Key: 19554500
• Report Number: 9612452-2024-00022
• Device Sequence Number: 6711608
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: (01)04038653918164
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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 Model Number: 5010024
• Device Lot Number: 36982159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown