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 Information (3190)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation since the device is currently in transit.A follow-up report will be provided once we receive and evaluate this device.At this time, we are inconclusive about the root cause of the defect.
Event or Problem Description
The balloon failed to deflate properly during embolectomy procedure.
Event or Problem Description
The balloon failed to deflate properly during embolectomy procedure.This is the follow-up report of the manufacturer's report# 1220948-2018-00060 that was initially submitted on 8/23/2018.
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.During our evaluation, we found that the section of the balloon beyond the distal ligature ( the catheter tip) also inflated although this section of the balloon was not designed to do so.This section of the balloon also failed to deflate although the main body of the balloon deflated properly.When the balloon was removed from the catheter, we observed a longitudinal cut on the distal groove of the catheter that extended above this groove.As a result, water was leaking through this hole and into the tip of the balloon.The root cause was determined to be an operator error- this section was accidently cut while trimming the flash after the welding process.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.There was no injury to the patient as the result of this incident.

• 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: 7809154
• Report Number: 1220948-2018-00060
• Device Sequence Number: 1012498
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 09/21/2018

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: Health Professional
• Device Expiration Date: 10/28/2023
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC4395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1