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

Catalog Number	1601-48
Medical Device Problem Codes	Material Separation (1562); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for investigation.Inspection of the catheter found it damaged due to excessive pull force during the procedure, as there is stretching/necking along the catheter and the catheter tip/balloon had detached from the catheter and could not be returned.As a result, it could not be determined if the product became stuck in the patient due to anatomical features (calcification/stenosis) or due to the catheter balloon failing to deflate as intended.Due to the damage, the balloon couldn't be tested to confirm the deflation issue.An x-ray was performed on the patient, but the missing part was unable to be located and retrieved.The status of the patient was requested and it was stated the patient was still in the icu due to the emergency operation for ruptured abdominal aortic aneurysm.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.
Event or Problem Description
The patient was admitted to hospital with a ruptured abdominal aortic aneurysm and needed an emergency downstream embolectomy.The catheter was inserted into the left iliac, and despite trying to deflate the balloon it wouldn't deflate and had difficulty pulling back and was stuck.The tip of the catheter snapped inside patient and was missing.An x-ray was performed on the patient, but they were unable locate the missing part to retrieve it.No other injury or complication was reported.The patient was still in the icu due to the emergency operation for ruptured abdominal aortic aneurysm.

• Brand Name: TUFTEX EMBOLECTOMY CATHETER
• Common Device Name: TUFTEX 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: 20653720
• Report Number: 1220948-2024-00220
• Device Sequence Number: 17802534
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: (01)00840663100491(11)230919(17)290828(10)XSL1595(91)1601-48
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: XSL1595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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