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

Model Number	1651-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was received for investigation and the reported event was confirmed.During testing, a hole was found in the balloon.When saline was inserted into the inflation lumen fluid exited the hole in the balloon preventing the balloon from inflating.The precise root cause of the hole in the balloon could not be determined, however due to the report of the device being used in a stenotic region, it is likely that anatomical features resulted in the observed damage.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
The surgeon stated that while using the tuftex over-the-wire embolectomy catheter, the balloon was ruptured while removing a clot.The device had been checked before use and the balloon was able to inflate without leakage.The recommended volume of saline was not exceeded.The surgeon believes that the catheter was used at a stenotic region.No balloon fragments were left in the patient's vessel.The operation was completed successfully using another product.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: 15457741
• Report Number: 1220948-2022-00101
• Device Sequence Number: 20546788
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: 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): 09/21/2022

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: 1651-44
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW4832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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