MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 CAROTID SHUNT; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	2012-12
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.Both balloons were completely deflated when we received the device.When we inflated the balloons with recommended volume of 1.5 ml for common carotid balloon and 0.25 ml for internal carotid balloon, the balloons inflated as expected.When the balloons were deflated by pulling the plunger of the syringe, they deflated as expected.We were able to recreate the issue only when the plunger of the syringe was not pulled and was left to deflate unassisted.This device passed all of our specifications.When the inflation lumen was inspected, we did not find any blockage that could have prevented the balloon from deflating.Also the joint between the inflation arm and the irrigation lumen was found bonded as expected.All of the (b)(4) units manufactured in this lot have been sold.We have not received any other complaints from other customers related to a similar issue.Our review of manufacturing batch records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.The lot was inspected 100% for balloon function.No issue was noted during the inspection.There was no injury to the patient as the result of this incident.The root cause of the issue remains inconclusive.It is possible that the anatomy of the patient along with the doctor's technique might have contributed to this incident.
Event or Problem Description
During a carotid endarterectomy, the surgeon could not deflate the internal carotid balloon of the shunt.Surgeon then pulled the lumen of the shunt to remove the inflated balloon.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6862598
• Report Number: 1220948-2017-00053
• Device Sequence Number: 1312730
• Product Code: MJN
• UDI-Device Identifier: 00840663101238
• UDI-Public: 00840663101238
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: 2012-12
• Device Lot Number: PFT3115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1