MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT AORTIC OCCLUSION CATHETER

Catalog Number	2100-12
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.When we attempted to inflate the balloon with saline, we observed a leakage at the joint of the inflation arm and the irrigation lumen.The root cause of the issue was determined to be a manufacturing operator error- not enough glue was applied on the joint during assembly process.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.Therefore, we believe that it was an isolated incident.The malfunction was detected by the user during pre-use check.Device was not used in the patient.Procedure was completed using another pruitt aortic catheter that they had in stock.
Event or Problem Description
During pre-use check, surgeon detected a leakage at the joint where the inflation arm meets the irrigation lumen.Device was not used in the patient.Surgeon completed the procedure using another pruitt aortic occlusion catheter that they had in stock.

• Brand Name: PRUITT AORTIC OCCLUSION CATHETER
• Common Device Name: AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8920512
• Report Number: 1220948-2019-00106
• Device Sequence Number: 2029013
• Product Code: DQT
• UDI-Device Identifier: 00840663101511
• UDI-Public: 00840663101511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K872090
• 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): 08/21/2019

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: 05/28/2023
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1