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

Model Number	e1651-84
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the failure.During the follow-up with the contact person at the hospital, we learned that the failure occurred when pulling the arterial plug back into the venous side of the graft.Based on our investigations for similar incidents, it is possible that the balloon was not tied sufficiently to the catheter.It is also possible that some anatomical (calcification or stenosis in the lesion area) or procedural factors (use of excessive force to remove the thrombus) may have contributed to the balloon failure.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque or overinflated balloon.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.Based on this incident and similar incidents reported by other users, we are preparing to initiate a recall on certain lots of lemaitre 5 french plus over-the-wire embolectomy catheters.The scope of the recall is currently being evaluated.There was no injury to the patient as the result of this incident.This is report# 1 of 5.Please note that we have also reported manufacturer's incident report# 1220948-2020-00027, 1220948-2020-00028, 1220948-2020-00030 and 1220948-2020-00031 relating to other 4 similar incidents that was reported to us by the same contact person at the hospital.
Event or Problem Description
During a thrombectomy procedure, the balloon of an over-the-wire embolectomy catheter failed to deflate after pulling the arterial plug into the graft.So, the surgeon punctured the balloon and removed the catheter from the patient's vessel.There was no injury to the patient as the result of this incident.This is report 3 of 5.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• MDR Report Key: 9817823
• Report Number: 1220948-2020-00029
• Device Sequence Number: 754271
• Product Code: DXE
• UDI-Device Identifier: 00840663100859
• UDI-Public: 00840663100859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022145
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

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 Model Number: e1651-84
• Device Catalogue Number: E1651-84
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/11/2020
• 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