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

Catalog Number	1651-38
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter was prepared and inserted into the vessel.The balloon was then inflated with the diluted contrast medium.During the thrombectomy, an attempt was made to deflate the balloon, but it was difficult to deflate as it took longer than usual.Therefore, this catheter was no longer used and a new catheter of the same size was prepared.The operation was successfully completed with replacement catheter.No injury was reported to the patient.
Additional Manufacturer Narrative
We have received the device for investigation.The reported problem was confirmed.During testing the balloon failed to deflate.When filling/attempting to deflate the balloon resistance was felt indicating a blockage in the inflation path.When the lumen of the device was cut approximately half way along the catheter the blockage was found and fluid was able to pass through the remaining portion of the lumen.The exact source of the blockage in the inflation lumen could not be identified.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.

• Brand Name: TUFTEX OVER-THE-WIRE 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 18419234
• Report Number: 1220948-2023-00195
• Device Sequence Number: 7867581
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: (01)00840663100668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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 Catalogue Number: 1651-38
• Device Lot Number: OTW4861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2022
• 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