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

Catalog Number	1651-44J
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was report the balloon ruptured during the initial thrombectomy procedure.The operation was successfully completed using a replacement.No injury was reported to the patient.
Additional Manufacturer Narrative
The device was returned for evaluation.The balloon of the catheter was found ruptured.While the damage was confirmed, the precise cause of the balloon rupture could not be confirmed.The ifu provides the following warning related to the complications possible when using these devices: 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.Exercise caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.Excessive handling during insertion, or plaques and other deposits within the vessel may damage the balloon and can increase the possibility of balloon rupture.The possibility of balloon rupture must be taken into account when considering the risks involved in the catheterization procedure.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.Capa 2021-009 was previously opened to address this issue.No further action needed at this time.

• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 17776763
• Report Number: 1220948-2023-00153
• Device Sequence Number: 6169889
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: (01)00840663100675
• 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): 09/19/2023

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 Expiration Date: 03/28/2025
• Device Catalogue Number: 1651-44J
• Device Lot Number: XOT1237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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