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

Catalog Number	1601-48
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not received for investigation.Therefore, we're unable to conclusively determine the root cause of the incident.Balloon ruptures are an inherent risk of using this product.As stated in the ifu: as with all catheterization procedures, complications may occur.These may include but are not limited to: infection, local hematomas, intimal disruption, arterial dissection, perforation and rupture, hemorrhage, arterial thrombosis, distal emboli of blood clots or arteriosclerotic plaque, air embolus, aneurysms, arterial spasms, arteriovenous fistula formation, balloon rupture or tip separation with fragmentation and distal embolization.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.Note: this is report 3 of 3 related to the third catheter used in the event.Reports 1220948-2024-00235 and 1220948-2024-00236 were submitted for the first and second devices involved in this event.
Event or Problem Description
It was reported that this tuftex 4f was the third device used to retrieve old thrombotic material from the anastomosis, but it also ruptured at the second passage.The thrombus removal was incomplete.No injury was reported to the patient.Note: this is report 3 of 3 related to the third catheter used in the event.Reports 1220948-2024-00235 and 1220948-2024-00236 were submitted for the first and second 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 ; 9784251683
• MDR Report Key: 20776987
• Report Number: 1220948-2024-00237
• Device Sequence Number: 15432275
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: (01)00840663100491(11)230206(17)290128(10)XSL1276(91)1601-58
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: XSL1276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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 Age: 62 YR
• Patient Sex: Unknown