MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3-S CAROTID SHUNT; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, PRODUCT CODE: MJN

Catalog Number	2014-10
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the explanted complaint graft for evaluation and we have confirmed the reported incident.During testing, the blood was observed to be leaking from the entire body of the graft.We did not observe any holes in the graft that could have caused this leakage.We have conducted a lot history records review for this product, which did not reveal any discrepancies during the manufacturing processes that could be related to the complaint event.Specifically, the physical incubation test (which measures how well the collagen was cross-linked) performed on a piece of this exact graft performed within its specification.Blood permeability and water permeability tests, performed on a sample of the grafts from this lot number also demonstrated that the grafts from this lot performed as expected at the time of release.From the information obtained in our investigation and the successful lot testing results noted above, we believe that the device should have been performing within its specification limits for acceptability (grafts have a permeability requirement of <0.1ml/min/cm2).A visual inspection was performed on this same exact graft on december 10, 2015.The inspection procedure confirmed that the collagen was properly distributed over the entire surface of the graft.Surgeon was able to complete the procedure by using another graft from the same lot number as the complaint graft without any issue.We have sold (b)(4) grafts that were manufactured under this lot number.We have not received any other complaints of a similar nature for devices from this lot.Hence, we consider the incident to be isolated to only this specific graft.
Event or Problem Description
During abdominal aorta aneurysm (aaa) repair using an albograft polyester vascular graft, surgeon observed the graft to be permeable after completing the distal anastomosis.The bleeding occurred throughout the entire graft but it was more prominent at the site of bifurcation.Approximately 1.5l of blood was lost due to this leakage.
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the defect with the internal carotid balloon.The internal carotid balloon inflated irregularly when inflated with 0.5 ml of air.The common carotid balloon inflated normally.Both balloons were able to deflate properly.Our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.Each of the common and internal carotid balloons are inflated with air using a syringe and then inspected to ensure balloons open concentrically.However, it is possible that during manufacturing, the balloons in this device were poorly assembled which led to non-concentric inflation of the balloon.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of similar nature for devices from this lot.We currently have a capa (corrective action preventive action) open to address this issue.There was no injury to the patient or any intervention from the surgeon.However, he experienced difficulty during anastomosis since blood was leaking out of the artery due to incomplete occlusion of the artery.
Event or Problem Description
During carotid endarterectomy, the internal carotid balloon failed to inflate properly.As a result, blood was leaking out from the patient's vessel during anastomosis since the balloon was unable to completely occlude the artery.This is a follow-up report of manufacturer's incident report 1220948-2018-00059 that was initially provided on (b)(6) 2018.

• Brand Name: PRUITT F3-S CAROTID SHUNT
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, PRODUCT CODE: MJN
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7952761
• Report Number: 1220948-2018-00059
• Device Sequence Number: 14015088
• Product Code: MJN
• UDI-Device Identifier: 00840663103423
• UDI-Public: 00840663103423
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2019
• Device Catalogue Number: 2014-10
• Device Lot Number: PFP1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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