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

Model Number	1651-38
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.The reported issue could not be confirmed and the root cause could not be determined.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
During pre-use check, an inflation test on the tuftex over-the-wire embolectomy catheter found the balloon was unable to deflate.The operation was successfully completed using another catheter.The product was not used on the patient.

• 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: 15676296
• Report Number: 1220948-2022-00111
• Device Sequence Number: 20425344
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: 00840663100668
• 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): 10/26/2022

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: 1651-38
• Device Catalogue Number: 1651-38
• Device Lot Number: OTW4657
• 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: 09/27/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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