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

Catalog Number	E2013-10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.We observed that the internal carotid balloon inflated non-concentric when it was inflated with 0.25 ml of saline while the common carotid balloon inflated concentric when it was inflated with 1.5 ml of saline.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 inflate concentric.At this time, we could not conclusively determine the root cause of the defect.It is possible that the balloon was not stretched uniformly during assembly process that led to a non-concentric inflation of the internal carotid balloon and this defect was missed during the inspection 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.While the root cause is inconclusive, the current rate of reported incidents for these kinds of defect is (b)(4) for the last 5 years for this product line.Based on our risk documents, the current rate of occurence is within our expected rate of occurence.Hence, no corrective action will be taken at this time.Device was not used for the procedure.The operation was completed using another f3 shunt that the hospital had in stock.
Event or Problem Description
During pre-use check, the balloons of the f3 shunt failed to inflate symmetrically when the balloons were inflated with recommended volume of saline.

• 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: 8417936
• Report Number: 1220948-2019-00024
• Device Sequence Number: 11344679
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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: 10/28/2019
• Device Catalogue Number: E2013-10
• Device Lot Number: PFT2902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1