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

Model Number	5010028
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: batch history review is not possible because neither batch number is unknown.The involved device is not available for investigation; the filter is still implanted in the patient's body.A x-rays picture was forwarded for analysis.It shows two distorted stabilizers but it does not allow us to determine the origin of the incorrect filter deployment.Conclusion: the elements received do not allow us to determine the root cause of this incident.There is no upward trend on similar incidents.No corrective action is envisaged.B braun medical sas has provided all the information currently available.In spite of all reasonable efforts being made to obtain further information, at this time we have not met with success.
Event or Problem Description
Upon placement, the filter did not open and one leg is extending outside the filter profile.Pre-placement cavogram is not available for review.The final film taken after implantation is available.The indication for filter implantation is unknown.The approach was jugular.The diameter of the vena cava before implantation is unknown.A second filter was not used to complete the procedure.Physician reports that the patient is very ill and the account does not expect any further intervention regarding this filter.There was no pressure felt or catching of the hooks in the distal portion of the sheath.Very flat ivc and the fellow deployed it probably by pushing it forward, so it caught on the wall.

• Brand Name: VENATECH CONVERTIBLE FILTER
• Common Device Name: VENA CAVA FILTER SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 10906179
• Report Number: 9612452-2020-00043
• Device Sequence Number: 11439550
• Product Code: DTK
• UDI-Device Identifier: 04027478130752
• UDI-Public: 04027478130752
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 Model Number: 5010028
• Device Catalogue Number: 5010028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other