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

Model Number	1651-38
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
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 both ligature and balloon were intact.However, the proximal ligature has slipped above the inflation hole.As a result, the balloon remained undeflated.During our follow-up investigation with the complainant, we learned that the surgeon had tested the catheter before use and he found it to be operational.Surgeon had made multiple passes to remove the clot from the patient's vessel before encountering the deflation issue with the balloon.He was able to remove the undeflated balloon from the patient's vessel without requiring any surgical intervention.He further stated that the balloon was operated in a patient with stenotic vessel.There were no fragments left over inside the patient's vessel when he removed the catheter from 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.After receiving this complaint, we have also tested a sample of catheters from this lot number.The tested catheters performed within its specification when they were pull tested to their validated force.Based on the information provided and our device evaluation, the device had performed properly during initial use.The issue might have occurred when removing the residual adherent thrombus from the patient's vessel.It does not appear to be an assembly issue since the user was able to make multiple passes successfully with this device and a sample of units from this lot number that we pull tested also met specification.It is possible 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 failure.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 injury to the patient as the result of this incident.The remaining procedure was completed using another lemaitre over-the-wire embolectomy catheter.Please note that we have also submitted manufacturer incident report# 1220948-2020-00046 related to another similar incident that occurred during the same case following the aforementioned incident.
Event or Problem Description
During a thrombectomy procedure, the balloon of an over-the-wire embolectomy catheter failed to deflate.Surgeon had to pull the catheter to remove the undeflated balloon from the patient's vessel.There was no injury to the patient as the result of this incident.This is report 1 of 2.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• MDR Report Key: 9924923
• Report Number: 1220948-2020-00045
• Device Sequence Number: 2438125
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: 00840663100668
• 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): 04/02/2020

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: 08/28/2025
• Device Model Number: 1651-38
• Device Catalogue Number: 1651-38
• Device Lot Number: OTW4279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1