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

Model Number	1651-34
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since the device has been discarded by the user.Hence, we could not conclusively determine the root cause of the malfunction.Surgeon acknowledged the presence of calcified plaque in the treatment area.Based on the information provided to us, it is possible that the balloon ruptured upon contact with the calcified plaque.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.Our ifu 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.We recommend exercising caution when encountering extremely diseased vessels.There was no injury to the patient as the result of this incident.Surgeon used a second over-the-wire embolectomy catheter to complete the procedure.
Event or Problem Description
When the catheter shaft was inserted into the blood vessel and the balloon was inflated, the balloon immediately ruptured.There was calcification at the treatment area.The procedure was successfully completed using another lemaitre over-the-wire 4f embolectomy catheter.There was no injury to the patient as the result of this incident.

• Brand Name: 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: 10938379
• Report Number: 1220948-2020-00114
• Device Sequence Number: 4294762
• Product Code: DXE
• UDI-Device Identifier: 00840663100651
• UDI-Public: 00840663100651
• 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): 12/01/2020

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: 10/28/2025
• Device Model Number: 1651-34
• Device Catalogue Number: 1651-48
• Device Lot Number: 00840663100682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1