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	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation could not be performed since the surgical team at the hospital had discarded the complaint device.So, we were unable to determine the exact root cause of this device failure.Device was checked before use and was found to be functional.Both balloons in the shunt worked properly throughout the entire endarterectomy procedure.It was after completion of the procedure, surgeon encountered this issue as he was unable to deflate the internal carotid balloon by aspirating the saline in the balloon.So, he had to puncture the balloon in order to deflate it.No further intervention was needed.Surgeon was able to remove the entire balloon without any balloon fragmentation.We reviewed the lot history records for this lot number and did not find any discrepancies that would contribute to this incident.Our complaint history analysis showed that no other similar complaints were found on this lot number.Hence, we consider this event to be an isolated incident.Our manufacturing team does conduct 100% inspection on each device and tests them for balloon functionality.Each balloon is inspected to ensure they inflate and deflate properly.No further information was provided by the treating surgeon.Since the balloon operated properly during pre-use check and during use, it is possible that some anatomical or procedural factors may have contributed to this issue.
Event or Problem Description
Surgeon was unable to remove the internal carotid balloon from the patient's internal carotid artery after completion of carotid endarterectomy procedure.So, he punctured the balloon with a needle to deflate the balloon and was then able to remove it.No further intervention was needed.The surgical team tested the device before the procedure and both balloons were found to be functional.

• 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: 8532733
• Report Number: 1220948-2019-00045
• Device Sequence Number: 2458503
• Product Code: MJN
• UDI-Device Identifier: 00840663101238
• UDI-Public: 00840663101238
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/19/2019

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: Health Professional
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: 2012-12
• Device Lot Number: PFT3393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1