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

Model Number	1651-44
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the surgeon, the balloon of the tuftex over-the-wire embolectomy catheter ruptured during an embolectomy procedure.He observed the ligature was loose and the balloon was deformed when it was removed from the patient's vessel.There was no harm to the patient because of this incident.
Additional Manufacturer Narrative
We have received the complaint device for evaluation, and we have confirmed the reported incident.We observed the proximal ligature had slipped from its initial location, covering the inflation hole.As a result, the surgeon could not deflate the balloon during the procedure.We did not observe any balloon rupture.We did not observe any stretching of the catheter lumen.Based on our investigation, it is possible that the balloon was not tied sufficiently to the catheter lumen.As a result, the proximal ligature slipped under stress when the surgeon attempted to pull the clot.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.Please note that our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter, including the risk of balloon failure due to exposure to calcified plaque.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G., chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.There was no harm to the patient because of this incident.The surgeon used another catheter to complete the procedure.

• Brand Name: TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15079778
• Report Number: 1220948-2022-00066
• Device Sequence Number: 4814152
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: 00840663100675
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: 02/01/2022
• Device Model Number: 1651-44
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW4818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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