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

Model Number	1651-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed the balloon of this catheter has ruptured.We did not observe any necking of the catheter extrusion.Both windings were properly held in place.We were able to flush the irrigation lumen and inflation lumen without any resistance.The surgeon had inspected the balloon prior to the procedure and he found it to be operational.Based on our device evaluation, it is likely that some anatomical (calcification or stenosis in the lesion area) or procedural factors ( use of excessive force to remove the thrombus) may have contributed to the balloon rupture.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.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 or overinflated balloon.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.Please note that we have also submitted manufacturer report# 1220948-2021-00058 related to another similar incident involving a 4f over-the- wire embolectomy catheter that occurred during the same case following this incident.
Event or Problem Description
This is report 1 of 2.The balloon of the 4f over-the-wire embolectomy catheter ruptured during an embolectomy procedure.So, surgeon used another 4f over-the-wire embolectomy catheter for the operation immediately.But, the balloon of this catheter also ruptured during the procedure.The surgeon then used a 5f plus over-the-wire embolectomy catheter and was able to complete the procedure successfully.There was no harm to the patient as a 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: 11986261
• Report Number: 1220948-2021-00057
• Device Sequence Number: 11603648
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: 00840663100675
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 1651-44
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW4714
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1