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

Catalog Number	1801-48
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
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.We observed a circumferential rupture of the balloon.The catheter was missing 6 mm of the balloon at its middle portion.No slippage of the ligature was observed.Although the initial report provided by the physician stated the balloon burst during pre-use check, based on our device evaluation, it is likely the balloon rupture occurred during the procedure.We were able to remove coagulated blood that was trapped inside the catheter lumen.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.
Event or Problem Description
The surgeon reported that during pre-use check, the balloon of the lemaitre novasil single lumen embolectomy catheter burst after inflating the balloon with 0.6 cc of saline.

• 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: 8740232
• Report Number: 1220948-2019-00078
• Device Sequence Number: 2566229
• Product Code: DXE
• UDI-Device Identifier: 00840663100927
• UDI-Public: 00840663100927
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/27/2019

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: 12/28/2022
• Device Catalogue Number: 1801-48
• Device Lot Number: NS1930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2019
• 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