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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
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 both common carotid balloon and internal carotid balloon inflated non-concentric when they were inflated with its recommended volume of saline.Both balloons were observed to have deflated properly when the saline inside the balloons were aspirated using a syringe.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 balloons and this defect was missed during the inspection process.We have recently addressed similar issues related to unsymmetrical inflation of the balloons by updating the design of this device which involves addition of an inflation hole which will assist the balloons to inflate symmetrically.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.Device was not used for the procedure.The operation was completed using another f3 shunt.
Event or Problem Description
During pre-use check, the balloons of the f3 shunt inflated unsymmetrically 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: 8740231
• Report Number: 1220948-2019-00076
• Device Sequence Number: 14094755
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: PFT3357A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1