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

Model Number	1651-68
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while checking the condition of the balloon inflation of the tuftex over-the-wire embolectomy catheter prior to use, it was found that the balloon was unable to deflate.No injury occurred.The operation was successfully conducted using another catheter of the same model.
Additional Manufacturer Narrative
The product was received for investigation.Inspection of the device confirmed the reported issue.The balloon was still inflated upon receipt of the device.The proximal ligature of the device was observed detached and slipped toward the distal end of the catheter, which moved the inflated portion of the balloon past the skive holes and resulted in the failure of the balloon to deflate.The device failed due to improper tying/gluing of the ligature during manufacturing.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.During manufacturing, 30 samples were selected for pull testing.All samples successfully passed the pull test.

• 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: 16601682
• Report Number: 1220948-2023-00041
• Device Sequence Number: 12565665
• Product Code: DXE
• UDI-Device Identifier: 00840663100729
• UDI-Public: (01)00840663100729
• 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): 03/23/2023

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 Model Number: 1651-68
• Device Catalogue Number: 1651-68
• Device Lot Number: OTW4859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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