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

Model Number 31335

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 10/01/2014

Event Type  Injury  

Event Description

"the filter was inadvertently placed incorrectly.One leg was in the left renal vein and the another leg in the right renal vein.Physician had a colleague help retrieve the filter.Another lp filter was placed without incident.".

Manufacturer Narrative

Batch history review: batch unknown.Review impossible.Investigation: the explanted filter was not returned for evaluation.However, the description of the incident indicates a wrong placement by the physician without defect malfunction.It is worth noting that the sheath and the pusher of the venatech lp vena cava system are equipped of a radio-opaque marker to allow a precise filter deployment.Conclusion: the filter wrong placement does not seem to be imputable to the device.This is an isolated case.No corrective action is envisaged.

• Brand Name: VENATECH LP VENA CAVA FILTER
• Type of Device: PERMANENT VENA CAVA FILTER
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; boulogne ; FR
• Manufacturer (Section G): B. BRAUN MEDICAL SAS; 30 avenue des temps modernes; chasseneuil, cedex ; FR
• MDR Report Key: 4478274
• MDR Text Key: 18919553
• Report Number: 9612452-2015-00003
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 1010485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/26/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention