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

Catalog Number	1601-48
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were discarded and not available for investigation.However, the provided photo confirmed the report.It shows the balloon fully inflated.The lower ligature was observed to have slipped from its intended position which caused the balloon to move past the skive hole and prevented the balloon from deflating.The ligature likely failed due to the pull force on the catheter during the procedure.It is possible that procedural factors including stenosis or calcified plaque caused additional pull force to be used during thrombus removal and contributed to the failure.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.Additionally, there have not been any previous complaints related to this lot number.The surgeon and the or team were reminded by the sales representative to always conduct a pre-use check prior use in a patient as requested in the directions for use of the ifu.This is report 4 of 4 related to the fourth catheter used in the event.Report 1220948-2023-00210, 1220948-2023-00211, 1220948-2023-00212 were submitted for the first, second, and third devices involved in this event.
Event or Problem Description
It was reported by the operating room nurse that four devices from the same lot had an issue with the balloon not deflating.The user stated no pre-use check was performed on the devices.No injury was reported to the patient.This is report 4 of 4 related to the fourth catheter used in the event.Report 1220948-2023-00210, 1220948-2023-00211, 1220948-2023-00212 were submitted for the first, second, and third devices involved in this event.

• Brand Name: TUFTEX 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: 18436296
• Report Number: 1220948-2023-00213
• Device Sequence Number: 15345362
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: (01)00840663100491
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: 1601-48
• Device Lot Number: XSL1357
• 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: 12/05/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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