MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SINGLE LUMEN EMBOLECTOMY CATHETER

Model Number	1601-44
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We have received two pieces of the catheter.During the procedure, surgeon cut the catheter shaft 3.7 cm above the 70-80 cm mark since he was unable to deflate the balloon.The short piece of the catheter (from catheter tip to the cut end) was measured to be 6.2 cm while the other end (from the cut end to the hub joint) was measured to be 74.2 cm.We did not observe any stretching of the catheter lumen.The ligatures were properly held in place and were measured to be within specification.We observed a section of the catheter shaft at both ends next to where it was cut to be damaged/crushed.When we attempted to flush the lumen by injecting liquid through the hub using a syringe, we were unable to inject liquid as a we experienced strong resistance while doing so.However, when we cut the crushed section of the lumen, we were able to easily flush the lumen without any resistance.Likewise.We were unable to insert a mandrel into the lumen of the short piece of the catheter because of the damage to the shaft.However, when we cut this segment, we were able to insert a mandrel into its lumen.We were able to inflate and deflate the balloon without any issue.Based on our device evaluation, it is likely that this section of the catheter was damaged during the procedure that prevented the balloon from deflating.Surgeon was able to remove the clot successfully during the first two passes.The malfunction occurred during third pass.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.
Event or Problem Description
For embolization of the left femoral artery, the catheter shaft of this product was inserted into the artery.And the clot was removed by pulling the catheter with inflated balloon (the first thrombectomy was completed successfully).In the same way, the second thrombectomy was performed with this product and completed successfully.While performing the third thrombectomy with this product, the balloon became unable to deflate, so the catheter could not remove from the artery.As a result, after performing surgical cutdown near the balloon and cutting the catheter shaft, the catheter shaft and catheter tip was surgically removed.Finally, the surgical procedure was changed from "thrombectomy" to "thrombo-endarterectomy (tae)" and this operation was completed successfully.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11205132
• Report Number: 1220948-2021-00002
• Device Sequence Number: 13988474
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2025
• Device Model Number: 1601-44
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC5163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/20/2021
• 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