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

Model Number	1651-48
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We have confirmed the reported incident.We observed the balloon of this catheter has ruptured.We were able to properly flush the irrigation lumen of the catheter.However, we experienced strong resistance when we attempted to flush the inflation lumen.When we cut the catheter lumen at 20 cm from the tip of the catheter, we observed glue-like tacky foreign particles inside the inflation lumen.As a result, we were unable to flush the inflation lumen.When we cut the inflation lumen at 30 cm from the tip of the catheter, we were able to flush the inflation lumen without any resistance.During the follow-up investigation, we were informed that the balloon ruptured when the surgeon attempted to inflate the balloon inside the patient's vessel.There was no balloon fragmentation as a result of this rupture that required any further intervention.The surgeon had inspected the device before use and he found it to be functional.The balloon was inflated with the recommended volume of saline.Based on our device evaluation, it is likely that the balloon came in contact with a calcified plaque as it was being inflated inside the patient's vessel.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.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 a result of this incident.The surgeon used a second over-the-wire embolectomy catheter to complete the procedure.
Event or Problem Description
The balloon of the lemaitre over-the-wire embolectomy catheter ruptured during an embolectomy procedure.There was no harm to the patient as the result of this incident.Surgeon used another over-the-wire embolectomy catheter to complete the procedure.

• 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: 12131874
• Report Number: 1220948-2021-00065
• Device Sequence Number: 19730954
• Product Code: DXE
• UDI-Device Identifier: 00840663100682
• UDI-Public: 00840663100682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K973334
• 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): 07/07/2021

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 Expiration Date: 06/28/2026
• Device Model Number: 1651-48
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW4504A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1