MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER

Model Number	1651-34
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved product was not returned for evaluation.Therefore the root cause of the reported event could not be determined.The device history record was reviewed.No manufacturing or packaging issues were noted that would result in the reported event.Additionally, we have not received any other complaints of a similar nature for other devices from this lot.The ifu provides the following warning: arterial rupture or balloon failure due to sharp calcified plaque may occur.The possibility of balloon rupture must be taken into account when considering the risks involved in the catherization procedure.There was no injury to the patient as a result of the incident.The surgeon used another device to complete the procedure.
Event or Problem Description
A tuftex over-the-wire embolectomy catheter was being used to remove a thrombus.Prior to use the balloon inflated properly.The catheter was inserted into the vessel and the balloon ruptured when pulling the catheter for the thrombectomy.Another device was use to complete the operation.No injury was reported.

• Brand Name: TUFTEX OVER-THE-WIRE 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: 15838138
• Report Number: 1220948-2022-00122
• Device Sequence Number: 5762123
• Product Code: DXE
• UDI-Device Identifier: 00840663100651
• UDI-Public: (01)00840663100651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022145
• 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): 11/21/2022

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: 1651-34
• Device Catalogue Number: 1651-34
• Device Lot Number: OTW4849
• 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: 10/24/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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