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

Catalog Number 5010028

Device Problems Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2020

Event Type  Injury  

Event 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: CONVERTIBLE VENATECH FILTER
• Type of Device: VENATECH FILTER
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; 26 rue armengaud; saint-cloud 92210 ; FR 92210
• MDR Report Key: 10787042
• MDR Text Key: 214651704
• Report Number: 3006332832-2020-00007
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 5010028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2020
• Distributor Facility Aware Date: 10/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other