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

Model Number	2100-12
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/17/2020
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 distal bond between the balloon and the catheter shaft.The root cause of the issue was determined to be an operator error- not enough glue was applied on the joint during the assembly process.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.Surgeon detected the malfunction during pre-use check.Device was not used for the procedure.He then used another pruitt aortic occlusion catheter for the procedure.
Event or Problem Description
During pre-use check, surgeon observed a leakage at the tip of the balloon when he attempted to inflate the balloon with saline.Device was not used for the procedure.

• Brand Name: PRUITT AORTIC OCCLUSION CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• MDR Report Key: 9837275
• Report Number: 1220948-2020-00034
• Device Sequence Number: 14311614
• 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): 03/16/2020

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: 07/28/2020
• Device Model Number: 2100-12
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1