MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS VENATECH CONVERTIBLE; OPTIONAL 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	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch history review: we have checked the manufacturing file of batch nr 36975684 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of filters released in march 2021.Investigation results:the filter is implanted in the patient's body.Nor the implantation accessories either any x-ray films were not returned for evaluation.Conclusion: without any x-ray films nor the implantation accessories, no thorough investigation is possible, and we cannot conclude on the real cause of the incident.There is no upward trend on similar incidents.No corrective action is envisaged.
Event or Problem Description
The filter was caught on the end of the sheath during deployment.As a result, a few of the legs misdeployed.

• Brand Name: VENATECH CONVERTIBLE
• Common Device Name: OPTIONAL 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: 13282402
• Report Number: 9612452-2022-00003
• Device Sequence Number: 4886319
• Product Code: DTK
• UDI-Device Identifier: 04027478130752
• UDI-Public: 04027478130752
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2022

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: 02/17/2026
• Device Model Number: 5010028
• Device Catalogue Number: 5010028
• Device Lot Number: 36975684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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: Other
• Patient Sex: Unknown