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	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We observed necking of the catheter lumen.We also observed a hole in the balloon.When we injected the liquid into the inflation lumen, the liquid ejected from the skive hole confirming that the inflation lumen was not completely occluded.Both of the ligatures were held in place properly.Based on our device evaluation, it is likely that the device was used excessive force during the procedure resulting in catheter necking.We have not received any other complaints of a similar nature for devices from this lot.Our ifu clearly/appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque and overinflated balloon.The arterial embolectomy catheter is not recommended for removing 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.
Event or Problem Description
According to the surgeon, the balloon of the tuftex over-the-wire embolectomy catheter slipped during an embolectomy procedure.There was no harm to the patient because of this incident.

• 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: 14657358
• Report Number: 1220948-2022-00052
• Device Sequence Number: 3626090
• 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): 06/10/2022

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: OTW4821
• 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: 06/11/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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