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

Model Number	5010028
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation result will be completed in a follow-up report.
Event or Problem Description
"convertible ivc filter was placed but did not self expand.Dr (b)(6) was able to get a catheter through the filter and inflate a balloon to get the filter to expand.He had to assist several different sides before full expansion was achieved.".
Event or Problem Description
"convertible ivc filter was placed but did not self expand.Dr (b)(6) was able to get a catheter through the filter and inflate a balloon to get the filter to expand.He had to assist several different sides before full expansion was achieved.".
Additional Manufacturer Narrative
Device history record batch record file number 37027617 was reviewed: the batch was manufactured within the specifications and no discrepancy was observed during inspection steps.No similar complaint was reported on the batch released in july 2024.Summary of investigation no involved device was returned for investigation.The involved filter was successfully implanted after the reported event.No x-ray picture taken before or during the reported event was returned for evaluation.- raw material historical review: the raw material used for the vena cava filter batches included in the device kit was verified.The incoming quality controls were within the defined specifications and no abnormality was detected.- complaints database review: the complaint data base was verified: no increasing trend for this type of incident has been highlighted.Root cause the received elements and information do not allow us to conclude on the real cause of the incident encountered by the customer.The filter non-opening after release is a known defect of the vena cava filter implantation.Without the involved sample, conclusive pictures/videos of the event, no root cause can be identified.Conclusion no thorough investigation can be performed without the concerned sample/conclusive picture-video, preventing the determination of the root cause of the met event.This type of incident is rare.No actions plan is foreseen at that time.

• Brand Name: VENATECH CONVERTIBLE
• 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: 21412565
• Report Number: 9612452-2025-00013
• Device Sequence Number: 18505558
• Product Code: DTK
• UDI-Device Identifier: 04027478130752
• UDI-Public: (01)04027478130752(11)240703(17)290703(10)37027617
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K152765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Model Number: 5010028
• Device Lot Number: 37027617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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