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	07/20/2018
Type of Reportable Event	Malfunction
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 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.We have made our manufacturing operators aware of the incident.We believe this awareness will act to minimize the issue in future.The issue was detected during pre-use check.The procedure was completed using a new lemaitre embolectomy catheter.
Event or Problem Description
During pre-use check, surgeon inflated the balloon of a single lumen catheter using saline.Upon inflation, he observed that a section of the balloon beyond distal ligature also inflated.However, this section of the balloon failed to deflate when he pulled the plunger of the syringe although the section of balloon below the distal ligature deflated properly.

• 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: 7794413
• Report Number: 1220948-2018-00058
• Device Sequence Number: 1197785
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (Y/N): N
• 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): 08/17/2018

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: 11/28/2023
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC4417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1