MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LEMAITRE EMBOLECTOMY CATHETER

Model Number	1601-48
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During embolectomy, the surgeon inserted the catheter into the patient's blood vessel and performed the procedure as usual.He had to pull the clot with a higher force than usual.Because there was still a clot in the blood vessel, the surgeon attempted to insert the catheter back into the vessel to perform the procedure again.However, this time, the catheter could not enter the vessel.Through inspection, he found that the body of the catheter was deformed and he had to use another catheter to remove the residual clot.There was no harm to the patient because of this incident.
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.However, we have observed the reported incident in the picture that was provided to us.We observed excessive necking of the catheter lumen.We also observed the tip of the catheter was deformed and the catheter lumen next to the proximal ligature was also excessively stretched.Based on the photographic evaluation of the complaint device, it is likely that the surgeon used excessive force to remove the adherent clot from the patient's vessel.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.Our ifu clearly/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 and 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.There was no harm to the patient because of this malfunction.

• Brand Name: LEMAITRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 13314918
• Report Number: 1220948-2022-00003
• Device Sequence Number: 11187869
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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: 12/28/2025
• Device Model Number: 1601-48
• Device Catalogue Number: 1061-48
• Device Lot Number: SLC5263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown