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

Catalog Number	E2013-10
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed a leakage at the bushing-stopcock joint of the common carotid balloon's inflation arm when we attempted to inflate the common carotid balloon with 1.5 cc of liquid.Internal carotid balloon inflated properly when it was inflated with 0.25 cc of liquid and the balloon deflated properly as well.No leakage was observed at the bushing-stopcock joint of the internal carotid balloon's inflation arm.Upon further evaluation, we observed adequate amount of glue on the stopcock joint of the common carotid balloon's inflation arm.However, the liquid was observed to be seeping out through a gap between the inflation arm and the glue bond.We have also inspected another f3 shunt from the same lot number that was returned to us by the hospital.We did not observe any defect in this device.Both balloons inflated and deflated properly.We did not observe leakage from any joints.We were able to recreate similar defect in this device by forcefully rubbing the joint against a hard surface.At this time, we remain inconclusive about the root cause of the defect.However, it is possible that the device was handled aggressively at the user facility.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.We currently have a corrective and preventive action (capa) open to address this issue and prevent them from reoccurring.The malfunction was detected during pre-use check by the surgeon.This device was not used for the procedure.
Event or Problem Description
During pre-use check, when the nurse inflated the common carotid balloon with saline, she detected a leak at a joint between the stopcock and the common carotid balloon inflation arm.

• 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: 8692777
• Report Number: 1220948-2019-00066
• Device Sequence Number: 11254897
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/12/2019

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: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1