MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER; EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER

Catalog Number	1601-38
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and investigated on 7/26/2016 with engineering.There was a kink noted at the proximal end of the tube likely caused due to excessive force applied during the procedure.This likely occured because of the balloon being stuck on the calcified plaque.Form fda 3500a was originally submitted on 07/28/2019 though mail.However, on 8/22/2016, we receive the form back from fda stating to submit the form electronically.Uf/importer report# (b)(4).
Event or Problem Description
Patient had an acute rupture of the aorta, once brought under control and repaired.The surgeon used a 4fr and then a 3fr embolectomy catheter to remove debris from the iliac, sfa and eventually the proximal popliteal.It was after removing the 3fr catheter from the calcified distal vessel that he noticed the balloon/end of the 3fr catheter was missing.

• Brand Name: LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 5906302
• Report Number: 1220948-2016-00013
• Device Sequence Number: 22756
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2016

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: Physician
• Device Expiration Date: 10/21/2021
• Device Catalogue Number: 1601-38
• Device Lot Number: SLC3804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2016
• Initial Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other