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	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the malfunction.A batch record review could not be performed since the lot number of the device is unknown at this time.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
During thrombectomy, when surgeon inflated the balloon of the over-the-wire embolectomy catheter inside the patient's vessel, the balloon ruptured.Another over-the-wire embolectomy catheter was used to complete the procedure.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
• MDR Report Key: 10489547
• Report Number: 1220948-2020-00090
• Device Sequence Number: 19726748
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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 Model Number: 1651-34
• Device Catalogue Number: 1651-34
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1