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

Model Number	1651-84
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 product was received for investigation and the reported event was confirmed.The balloon was observed to be ruptured.The precise root cause of the ruptured balloon could not be determined.The ifu provides the following warning regarding the possibility of the balloon rupturing during use: 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 craterization procedure.Review of the lot record did not find any issues that would contribute to the event.Additionally, we have not received any other complaints of a similar nature for devices from this lot.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.During pre-use check there were no issues.After inserting the catheter into the blood vessel and pulling the catheter for the thrombectomy the balloon ruptured.Another product was used as a substitute to complete the procedure.No injury occurred.

• 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: 15837800
• Report Number: 1220948-2022-00121
• Device Sequence Number: 12119449
• Product Code: DXE
• UDI-Device Identifier: 00840663100743
• UDI-Public: (01)00840663100743
• 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 Expiration Date: 08/28/2026
• Device Model Number: 1651-84
• Device Catalogue Number: 1651-84
• Device Lot Number: OTW4602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• 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): Yes
• Date Device Manufactured: 09/23/2020
• 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