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

Catalog Number	1601-38
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Rupture (1546)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded by the hospital.Hence, we could not conclusively determine the root cause of the defect.All of the (b)(4) units of catheter manufactured under this lot number have been sold.We have not received any other complaints related to similar incident from other customers.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.We therefore believe this is an isolated incident.It is likely the balloon got caught on the calcified region of the plaque causing the balloon to dislodge from the shaft when pulling the balloon during embolectomy.There was no injury to the patient as the result of this incident.Although we have requested the hospital multiple times for additional information on the incident, we have not heard anything back from the hospital.
Event or Problem Description
Tip of the catheter broke during usage.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETERS
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6836198
• Report Number: 1220948-2017-00050
• Device Sequence Number: 496076
• Product Code: DXE
• UDI-Device Identifier: 00840663100583
• UDI-Public: 00840663100583
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/31/2017

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: 02/28/2022
• Device Catalogue Number: 1601-38
• Device Lot Number: SLC3886
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1