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

Model Number	5010028
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch history review: the manufacturing process has been reviewed.No abnormality was detected.The filter batch involved in this complaint has been manufactured in accordance with our sop.Investigation: the venatech convertible filter is a device which can be placed either by femoral or jugular approach.A color code and a drawing on the filter delivery system gives the user the information to enable him/her to choose the correct orientation.In this case the filter was implanted upside down due to the fact that the physician has oriented the delivery system for jugular approach whereas the chosen route was the left femoral vein.It is worth noting that: - the manufacturing process is such that the filter cannot be placed upside down in the cartridge.- the orientation of the filter inside the delivery system is 100 % controlled before packaging.- the delivery system which allows jugular or femoral insertion has been designed with a color code to clearly indicate the orientation of the device - to avoid mis-orientation of the device, the ifu for the venatech convertible is divided in two booklets: one for jugular approach, the other for femoral approach.Ie the femoral booklet states: "this booklet is to be used only when the femoral approach for filter implantation is selected.Do not use this booklet for any other filter implantation approach." this is an isolated incident, not directly imputable to the device.Consequently no corrective action is envisaged.
Event or Problem Description
After a venacavagram was completed, the convertible filter was deployed via the left femoral vein.After deployment, fluoroscopy showed the convertible filter to be upside down.The physician then deployed a lp filter via the left femoral vein through the convertible sheath.Placement of the lp filter was above the convertible filter.Physician was positioned at the table on the left side of the patient for the duration of the case.Filter location: infrarenal.Indication for filter implantation: suspected dvt in lower right leg.Time frame of event: during implant.No adverse event noted.Account confirmed that the cartridge was in the incorrect orientation for implantation.Dr.Arts successfully converted the convertible filter on (b)(6) 2017 from the right femoral approach using sos omni-flush, 20mm amplaztz gooseneck snare.Cava was open.Pt was released.

• Brand Name: VENATECH CONVERTIBLE
• Common Device Name: OPTIONAL VENA CAVA FILTER
• Manufacturer (Section D): B .BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne billancourt, 92100 ; FR 92100
• MDR Report Key: 6539873
• Report Number: 9612452-2017-00022
• Device Sequence Number: 16165675
• Product Code: DTK
• UDI-Device Identifier: 04027478130752
• UDI-Public: 04027478130752
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2017

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
• Operator of Device: Physician
• Device Expiration Date: 12/21/2020
• Device Model Number: 5010028
• Device Lot Number: 36904835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/03/2017
• 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: Required Intervention