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

Catalog Number	1801-38
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident with this returned catheter.The balloon of this catheter was observed to be ruptured.During the follow-up with the surgeon, we learnt that the balloon burst when the balloon was exposed to heavily calcified vessels.The catheter was used by the surgeon for embolectomy procedures as well for occluding the vessels.Surgeon confirmed that he was able to remove all of the balloon fragments from the vessel.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.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.There was no injury or any impact on the patient's health as the result of this incident.No corrective action is required.Our risk documents as well as the ifu properly addresses the risk of balloon rupture if exposed to calcified plaque.This is report 2 of 3.Please note that we have also submitted manufacturer's incident report 1220948-2019-00062 and 1220948-219-00064 that were reported by the same surgeon for similar incidents.
Event or Problem Description
The surgeon reported that the balloons of the lemaitre novasil single lumen embolectomy catheters burst during embolectomy procedure when the balloons were exposed to highly calcified vessel.This is report 2 of 3 of that series.

• 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: 8664930
• Report Number: 1220948-2019-00063
• Device Sequence Number: 16711520
• Product Code: DXE
• UDI-Device Identifier: 00840663100903
• UDI-Public: 00840663100903
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

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: 03/28/2023
• Device Catalogue Number: 1801-38
• Device Lot Number: NSE1952
• 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: 05/03/2019
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1