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

Catalog Number	E2012-13
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.We found that the ink marking on the lumen of the common carotid balloon where it says pruitt has partially flaked off.Our sales rep.Was present in the case with the physician but he could not confirm if the marking had already flaked prior to the start of the procedure.However, they noticed the defect during the procedure.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.Although we are inconclusive about the root cause of this issue, it is possible that the lumen of this particular shunt was not properly prepared prior to printing, resulting in poor ink adhesion.There was no injury to the patient as the result of this incident.
Event or Problem Description
During endarterectomy procedure, surgeon noticed the ink markings from the lumen of the shunt had flaked off.

• 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: 7908063
• Report Number: 1220948-2018-00072
• Device Sequence Number: 16378893
• Product Code: MJN
• UDI-Device Identifier: 00840663101245
• UDI-Public: 00840663101245
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 12/28/2019
• Device Catalogue Number: E2012-13
• Device Lot Number: PFT2921A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1