MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER

Model Number	1651-38
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation.Hence, we could not conclusively determine the root cause of this malfunction.We have received few pictures of the complaint device that was provided to us by the contact person at the hospital.We observed excessive necking of the catheter lumen and the catheter lumen appeared to have separated just above the y-connector.The balloon and the ligatures were properly positioned in the catheter lumen.We did not see any signs of ligature slippage in the provided pictures of the catheter.During the follow-up investigation with the contact person at the hospital, we were informed that the device was used for an embolectomy procedure of a right humerocephalic arteriovenous fistula.Surgeon experienced difficulty deflating the balloon.There was no impact in the patient's health as a result of this incident.Based on the photographic evaluation of the complaint device, it is likely that user used excessive force to remove the clot during the embolectomy procedure resulting in necking of the catheter lumen.As a result, the balloon failed to deflate during the procedure.However, without a hands-on device evaluation, we remain inconclusive about the root cause of the malfunction.As stated in the ifu, the arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material (eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.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 harm to the patient as the result of this incident.
Event or Problem Description
Rupture of the embolectomy catheter during surgery.The inflated balloon that had remained in the patient's artery could be removed anyway.As the integrity of the dms has been removed, closer monitoring of the patient was sufficient.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11276285
• Report Number: 1220948-2021-00005
• Device Sequence Number: 729028
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: 00840663100668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022145
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2025
• Device Model Number: 1651-38
• Device Catalogue Number: 1651-38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention