MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. NOVASIL SILICONE EMBOLECTOMY CATHETER

Model Number	1801-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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 and it was missing about 8 mm of the balloon piece in between the two windings.We did not observe any necking of the catheter extrusion.Both windings were properly held in place.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.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 or overinflated balloon.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.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.Surgeon used another lemaitre novasil embolectomy catheter of different size to complete the procedure.
Event or Problem Description
During thrombectomy in a dialysis patient, the balloon of the novasil silicone embolectomy catheter ruptured when removing the clot.Surgeon used another novasil silicone embolectomy catheter to complete the procedure.There was no harm to the patient as the result of this incident.

• Brand Name: NOVASIL SILICONE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11467452
• Report Number: 1220948-2021-00024
• Device Sequence Number: 4189175
• Product Code: DXE
• UDI-Device Identifier: 00840663100910
• UDI-Public: 00840663100910
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K992368
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: 10/28/2024
• Device Model Number: 1801-44
• Device Catalogue Number: 1801-44
• Device Lot Number: NSE2160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1