MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. NOVASIL LATEX-FREE EMBOLECTOMY CATHETER

Catalog Number	E1801-48
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint devices for evaluation.We have reached out to the contact person at the hospital for additional information relating to this incident.However, we did not received any response back.Hence, at this time, we could not conclusively determine the root cause of the balloon rupture with these devices.As stated in our ifu, the novasil silicone single lumen embolectomy catheter is indicated for the removal of arterial emboli and thrombi.The ifu properly addresses the risk associated with the use of these catheters.As in common with other catheterization procedures, complications including balloon rupture with fragmentation may occur with the use of these catheters.Our ifu also properly warns users not to expose the balloons to calcified plaque as it may increase risk of balloon rupture.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.The balloons of these catheters were tested by the user before pre-use check and were found to be operational.Based on this series of similar malfunctions that occured during the same procedure and on the same patient with two different kinds of catheter balloons ( latex and silicone), it is likely that some anatomical factors ( calcification or stenosis in the lesion area ) or procedural factors may have contributed to the balloon rupture.The surgeon could have also exposed these balloons to calcified plaque during the procedure despite ifu warnings to avoid these regions.However, without the returned devices, we are inconclusive about the root cause of these incidents.There was no injury or any impact on the patient's health as the result of this incident.Procedure was completed using another embolectomy catheter.Please note that we have also submitted manufacturer's report# 1220948-2019-000101 and 1220948-2019-00103 for the other cases of balloon rupture that occured during same procedure.
Event or Problem Description
The surgeon reported that during thrombectomy on one patient, the balloons of the three lemaitre emboctomy catheters ruptured.Two were silicone based balloons and one was a latex balloon.This is report 2 of 3 and describes a silicone based balloon failure.Report 1 of 3 describes another silicone based balloon failure and 3 of 3 describes a latex based balloon failure.

• Brand Name: NOVASIL LATEX-FREE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8880775
• Report Number: 1220948-2019-00102
• Device Sequence Number: 13929031
• Product Code: DXE
• UDI-Device Identifier: 00840663101047
• UDI-Public: 00840663101047
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K992368
• 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): 08/09/2019

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: 12/28/2023
• Device Catalogue Number: E1801-48
• Device Lot Number: NSE2048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1