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)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.We observed the balloon of this catheter had ruptured and the proximal ligature had slipped from its intended position and had migrated above the inflation hole.We did not observe any stretching of the catheter lumen.During the follow-up with the contact person at the hospital, we learned that the catheter was used to remove a fresh clot, a day old from a previously implanted graft in a dialysis patient for av access.Balloon was not checked before use because the surgeon wanted the lowest profile for the balloon so he can advance the tip beyond the thrombus.The balloon failed to deflate after pulling the arterial plug back into the venous side of the graft.Surgeon was able to remove the balloon by puncturing the balloon.The vessel of the patient had stenotic region at the arterial anastomosis.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.However, based on investigations for similar incidents, it is possible that the balloon was not tied sufficiently in the catheter.It is 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 rupture.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.
Event or Problem Description
During a thrombectomy procedure, the balloon of a 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.

• 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: 9811062
• Report Number: 1220948-2020-00026
• Device Sequence Number: 10951170
• 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 Expiration Date: 04/28/2025
• Device Model Number: e1651-84
• Device Catalogue Number: E1651-84
• Device Lot Number: OTW4193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/10/2020
• 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