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

Model Number	1651-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was received for evaluation and the reported issue was confirmed.The catheter was observed stretched and broken in the middle section of the catheter lumen.The user reported that the device likely came into contact with a calcified lesion during the procedure which resulted in the balloon getting caught.It is likely that excessive pull force to the catheter while attempting to remove the catheter from the lesion resulted in the observed damage.As stated in the ifu: exercise caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.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.All samples used for pull testing during manufacturing passed the test and met the required force before any damage occurred.
Event or Problem Description
It was reported that during a procedure using a tuftex over-the-wire embolectomy catheter after inflating the balloon inside the blood bessel, the balloon likely caught on a calcified lesion during the embolectomy so the physician could not pull out the catheter.As a result, the catheter shaft broke off in the middle.The catheter was able to be removed by pulling the broken portion.There were no remnants left inside the vessel.Another catheter was used to complete the operation.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: 16691300
• Report Number: 1220948-2023-00050
• Device Sequence Number: 17670125
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: (01)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): 04/06/2023

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: 1651-38
• Device Catalogue Number: 1651-38
• Device Lot Number: OTW4826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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