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

Catalog Number	1601-44
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation since the device has been discarded by the hospital.However, we were able to confirm the reported incident based on the picture that was provided to us by the hospital.A section of the balloon above the distal ligature failed to deflate.Device was tested before use and was found to be operational.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.At this time, we are inconclusive about the root cause of this issue.It is possible that the physician overinflated the balloon loosening the distal ligature that allowed water to leak into the tip of the balloon but was unable to escape when deflating the balloon.We currently have a corrective and preventive action (capa) opened to investigate the possible root causes of this issue.There was no injury to the patient as the result of this issue.Physician was able to recognize that the balloon did not deflate completely under fluoroscopy.He was able to remove the device from the patient's vessel without any complication.
Event or Problem Description
During embolectomy procedure, the physician could not deflate the balloon completely when removing the catheter out of the patient's artery.

• 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: 7643236
• Report Number: 1220948-2018-00043
• Device Sequence Number: 122163
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• 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): 06/27/2018

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: Physician
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC4362
• 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: 05/28/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1