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

Catalog Number	2100-12
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
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 liquid leaking from the balloon.We observed a cut on the proximal section of the balloon that resulted in this leakage.All of the balloon parts remained intact.Irrigation lumen flushed properly when irrigated with saline.Device was tested during pre-use check by the surgeon and was found to be operational.The catheter was inserted from the aortic arch towards the descending aorta.Balloon failed when it was inflated inside the stent graft.Based on our follow-up investigation and evaluation of the complaint device, it is likely the balloon of this catheter was punctured by a wire of the stent graft or some other sharp object during the procedure, damaging the balloon.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.Surgeon immediately replaced this catheter with another aortic occlusion catheter to occlude the vessel.There was no adverse event as the result of this incident.
Event or Problem Description
During an open stent-graft placement for treating aneurysm of a descending aorta, after properly placing the stent graft in his aorta, surgeon inserted an aortic occlusion catheter into the stent graft.He then inflated the balloon with saline at his desired location to occlude the vessel but it immediately ruptured.There was no injury to the patient as the result of this incident.Surgeon replaced the aortic occlusion catheter and continued the procedure.

• 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: 9130893
• Report Number: 1220948-2019-00133
• Device Sequence Number: 380693
• 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): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention