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 Information (3190)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation since the device is still in the possession of the hospital.Hence, we could not conclusively determine the root cause of the defect.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 these lots.The catheter was used in a graft on the fem-pop position and the physician did not experience any resistance when deflating the balloon.We could not receive any further information about the incident from the doctor.It is possible that the tortuous anatomy of the patient, calcified plaque if present in the patient's vessel and/or excessive tension on the device during the procedure could have led to this failure.We currently have a corrective and preventive action (capa) opened to investigate the possible root causes of this issue.The corrective action includes review of our manufacturing processes, materials and handling of the device.We have also made our manufacturing team aware of this issue.
Event or Problem Description
The lemaitre single lumen embolectomy catheter was used during an emergency intervention.The physician could not deflate the balloon completely when removing the balloon from the patient's vessel.

• 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: 7084737
• Report Number: 1220948-2017-00067
• Device Sequence Number: 1466480
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC4213
• 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: 11/06/2017
• Initial Report FDA Received Date: 12/05/2017
• 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: Death; Other
• Patient Age: 77 YR