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

Catalog Number	1651-48
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/28/2017
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.It is possible 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.Our sales rep.Had tried multiple times to get additional information about the incident from the hospital.However, he has not heard anything back from the hospital.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 similar nature for devices from this lot.We therefore believe this is an isolated incident.There was no injury to the patient as the result of this incident.
Event or Problem Description
While performing embolectomy, the distal tip separated from the catheter.

• Brand Name: OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6712387
• Report Number: 1220948-2017-00042
• Device Sequence Number: 19082520
• Product Code: DXE
• UDI-Device Identifier: 00840663100682
• UDI-Public: 00840663100682
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

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: 06/28/2020
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW2892
• 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: 06/14/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1