MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SINGLE LUMEN EMBOLECTOMY CATHETER

Catalog Number	1601-48
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation since the device has been discarded by the user.Hence, we could not conclusively determine the root cause of the failure.Based on our evaluation conducted for similar complaints, it is possible that during manufacturing, a section of this catheter lumen at its distal end was cut during trimming by the manufacturing operator after tip forming (welding) process.We have already made our manufacturing team aware of this issue.We have not received any new complaints related to those catheters that were manufactured after the awareness training.The current rate of occurrence for this issue for last 3 years is 0.001% which is within our expected rate of occurrence.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.There was no injury to the patient as the result of this issue.Please note that we have also reported another incident ( mfg report# 1220948-2019-00160) related to another lemaitre single lumen embolectomy catheter that was also reported to us by the same surgeon related to this same issue.
Event or Problem Description
During an embolectomy procedure, surgeon inflated a 4f lemaitre embolectomy catheter and inserted into the artery of the lower limb.Surgeon was able to partially remove the clot from the artery.However, he observed a section of the balloon beyond the distal ligature remained inflated despite the remaining section of the balloon had deflated properly.This is report 2 of 2 of this series.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9413607
• Report Number: 1220948-2019-00161
• Device Sequence Number: 13584186
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K051067
• 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): 12/02/2019

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: 05/28/2023
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC4254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1