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

Model Number	e1601-48
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloons of five tuftex embolectomy catheters ruptured during an embolectomy de-clot procedure.The products were retained at the hospital.No injury occurred.Please note that reports 1220948-2023-00058, 1220948-2023-00063, 1220948-2023-00065 and 1220948-2023-00066 were submitted for each device involved in this incident.
Additional Manufacturer Narrative
The product was not returned for evaluation.The exact cause of the reported balloon ruptures could not be determined.The exact cause of the issue could not be determined.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.Please note that reports 1220948-2023-00058, 1220948-2023-00063, 1220948-2023-00065 and 1220948-2023-00066 were submitted for each device involved in this incident.

• 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16771099
• Report Number: 1220948-2023-00064
• Device Sequence Number: 6386553
• Product Code: DXE
• UDI-Device Identifier: 00840663100606
• UDI-Public: (01)00840663100606
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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 Model Number: e1601-48
• Device Catalogue Number: E1601-48
• Device Lot Number: NSE2541
• 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: 03/24/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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