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U.S. Department of Health and Human Services

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

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B .BRAUN MEDICAL SAS VENATECH CONVERTIBLE OPTIONAL VENA CAVA FILTER Back to Search Results
Model Number 5010028
Device Problems Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2017
Event Type  malfunction  
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 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.
 
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Brand NameVENATECH CONVERTIBLE
Type of DeviceOPTIONAL VENA CAVA FILTER
Manufacturer (Section D)
B .BRAUN MEDICAL SAS
204 avenue du marechal juin
boulogne billancourt, 92100
FR 92100
Manufacturer (Section G)
B.BRAUN MEDICAL SAS
30 avenue des temps modernes
chasseneuil, 86361
FR 86361
Manufacturer Contact
catherine boismenu
30 avenue des temps modernes
chasseneuil, 86361
FR   86361
49627621
MDR Report Key6539873
MDR Text Key74320632
Report Number9612452-2017-00022
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/21/2020
Device Model Number5010028
Device Lot Number36904835
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/03/2017 Patient Sequence Number: 1
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