MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. NOVASIL SILICONE EMBOLECTOMY CATHETER

Model Number	1801-26
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation.Without the returned device, we remain inconclusive about the root cause of this malfunction.However, based on the information available to us, it is possible that user used excessive force when pulling the catheter and resulted in balloon/tip separation.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 similar complaints from this lot number.Hence, we consider this to be an isolated incident.
Event or Problem Description
During pre-use check, user tested the balloon functionality of the novasil embolectomy catheter by inflating the balloon with higher than recommended volume of air.He then manipulated the balloon between his fingers and then pulled the catheter.The balloon/tip separated from the lower part of the shaft and the balloon ruptured while doing so.There was no patient involvement.

• Brand Name: NOVASIL SILICONE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11457082
• Report Number: 1220948-2021-00023
• Device Sequence Number: 4189173
• Product Code: DXE
• UDI-Device Identifier: 00840663100880
• UDI-Public: 00840663100880
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K132022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 06/28/2024
• Device Model Number: 1801-26
• Device Catalogue Number: 1801-26
• Device Lot Number: NSE2106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1