MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LEMAITRE 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	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation since the complaint device has been discarded by the user.Hence, we could not conclusively determine the root cause of the defect.The surgeon stated that he observed necking of the catheter lumen near the y-connector after he removed the catheter from the patient's vessel.The necking of the catheter lumen likely occluded the irrigation lumen and prevented the balloon from deflating.Based on the limited information provided to us, it is possible that the user might have used excessive force to remove the clot during the thrombectomy procedure that resulted in a necking of the catheter lumen.But without the returned device, we remain inconclusive about the root cause of this defect.As stated in the ifu, the arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.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.Further, we have not received any other complaints of a similar nature.There was no harm to the patient because of this malfunction.
Event or Problem Description
During the thrombectomy procedure, when the surgeon attempted to deflate the balloon of the lemaitre over-the-wire embolectomy procedure, he was unable to deflate the balloon.He observed an elongation of the catheter extrusion near the y-connector.The surgeon then replaced the catheter to complete the procedure.There was no harm to the patient because of this incident.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• MDR Report Key: 12636656
• Report Number: 1220948-2021-00096
• Device Sequence Number: 5997213
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: OTW4731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1