MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 SHUNT

Model Number 2012-10

Device Problem No Apparent Adverse Event (3189)

Patient Problem Not Applicable (3189)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation, and we were not able to verify the failure mode.Lot history records review did not reveal any discrepancies related to the complaint event either during the manufacturing or packaging processes.We also have not received any other complaints for devices from the complaint lot.Therefore, the root cause(s) of the failure remains inconclusive.We have initiated an internal corrective and preventive action to investigate and address potential causes of the "balloon would not deflate" issue.Please note no patient injuries happened due to this incident.Note: the original submission of this report failed due to the software issue: cessub issue (b)(4).

Event Description

It was impossible to deflate the white (internal carotid) balloon during the procedure, the surgeon had to pop it through the artery with a needle and had to suture the needle incision on internal carotid.

• Brand Name: PRUITT F3 SHUNT
• Type of Device: PRUITT F3 SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• Manufacturer Contact: vyacheslav kozin ; 63 second ave.; burlington, MA 01803 ; 7812212266
• MDR Report Key: 5251883
• MDR Text Key: 32203303
• Report Number: 1220948-2015-00009
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: 00840663101214
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: 2012-10
• Device Catalogue Number: 2012-10
• Device Lot Number: PFT2753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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): Other