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

Model Number	e1601-26
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two tuftex embolectomy catheters had the balloon rupture during the procedure.No injury was reported.Please note that report 1220948-2023-00010 was also submitted related to this incident.
Additional Manufacturer Narrative
The product was not received for evaluation, therefore the root cause for the balloon rupture could not be determined.The lot number for the product involved in this event was not reported.Therefore, a lot history review was unable to be performed.As stated in the ifu, balloon ruptures are a known risk of using this product: in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, rupture of aneurysm, arterial spasm, distal embolus of blood clots or arteriosclerotic plaque, arterial dissection, and hemorrhage.Please note that report 1220948-2023-00010 was also submitted related to 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: 16356383
• Report Number: 1220948-2023-00011
• Device Sequence Number: 12329736
• Product Code: DXE
• UDI-Device Identifier: 00840663100552
• UDI-Public: (01)00840663100552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/10/2023

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: e1601-26
• Device Catalogue Number: E1601-26
• Device Lot Number: UNKNOWN
• 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: 01/11/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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