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

Catalog Number	1601-38
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we were able to confirm the reported incident.We found a leak at the hub joint.This defect would not cause or contribute to a death or serious injury if the malfunction was to recur.However, during our evaluation, we observed the balloon in this catheter inflated partially but was unable to deflate when the plunger of the syringe was pulled.So, we are providing this report as this malfunction can cause or contribute to a serious injury if the issue was to recur had it been used in a patient.We found a glue like particle inside the catheter that prevented the saline from exiting the balloon.As a result, the balloon could not deflate.The patient's vascular rate would never be exposed to this particle since it was contained inside the lumen of the catheter.We could not conclusively determine the source of this particle.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 similar nature for devices from this lot.Therefore, we believe that it was an isolated incident.Device was not used in the patient.
Event or Problem Description
The initial report received from the surgeon stated that the hub joint was leaking during pre-use check.During our evaluation, we observed that the balloon inflated partially but failed to deflate.

• 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: 7899713
• Report Number: 1220948-2018-00071
• Device Sequence Number: 11133928
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• 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): 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: 1601-38
• Device Lot Number: SLC4332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2018
• Initial 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