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

Catalog Number	1601-44
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we were able to confirm the reported defect.The balloon was non-concentric when the balloon was inflated with 0.75 ml saline.When we attempted to deflate the balloon, it failed to do so since one side of the balloon was covering the inflation holes and prevented the balloon from deflating.Our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.Each of the balloons are inflated with air using a syringe and then inspected to ensure the balloons open concentrically.Also, the balloons are tested to ensure the balloons deflate upon pulling the plunger of the syringe.However, it is possible that during manufacturing, the balloon in this catheter was poorly assembled which led to non-concentric inflation of the balloon.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.Further, we have not received any other complaints of a similar nature for devices from this lot.We therefore believe this is an isolated incident the issue was detected during pre-use check.Procedure was completed using a new lematire embolectomy catheter.
Event or Problem Description
During pre-use check, the physician injected 0.75 ml of saline to inflate the balloon.However, the balloon did not inflate symmetrically.

• 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: 7790812
• Report Number: 1220948-2018-00057
• Device Sequence Number: 1909229
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• 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): 08/16/2018

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: 01/24/2024
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC4475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1