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

Model Number	e1651-38
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since the device is currently at the hospital.However, we have observed the reported incident in the picture provided to us.The investigation is ongoing.We have requested the user to provide us with additional information relating to this incident.We have not yet received a response back form the customer.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 for devices from this lot.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 as the result of this incident.
Event or Problem Description
Tip broke off into the patient.No injury to patient.

• 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: 11029420
• Report Number: 1220948-2020-00122
• Device Sequence Number: 3562583
• Product Code: DXE
• UDI-Device Identifier: 00840663100774
• UDI-Public: 00840663100774
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2025
• Device Model Number: e1651-38
• Device Catalogue Number: E1651-38
• Device Lot Number: OTW4328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention