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

Catalog Number	1601-44
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.The entire proximal ligature has shifted upwards and was blocking the inflation holes.As a result, we were unable to inflate the balloon.The distal ligature was properly binding onto the balloon but was no longer holding the shaft of the catheter.No necking of the extrusion was observed.We observed dried glue on the surface of the groove of the catheter that binds with the proximal ligature.However, the glue was limited to only middle portion of the groove.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.As part of our manufacturing process, a 100% visual balloon and winding inspection are performed on the manufactured product.However, it is possible that the tension or the glue applied underneath the balloon during the balloon tying process was inadequate resulting in the slippage of the ligature from its position.During the follow-up, we also confirmed that the patient had avf stenosis.It is also possible that some anatomical or procedural factors may have contributed to the ligature failure while removing the adherent material from the patient's narrowed blood vessel.As stated in our ifu, the arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.We have recently implemented a corrective and preventive action (capa) to address this issue.There wa no injury to the patient as the result of this incident.
Event or Problem Description
During removal of an emboli from an arteriovenous fistula, the balloon of the single lumen embolectomy catheter malfunctioned.Upon removal of the catheter from the patient's vessel, surgeon observed that the ligature attached on both ends of the balloon had shifted.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: 8636411
• Report Number: 1220948-2019-00058
• Device Sequence Number: 13922303
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/21/2019

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: Health Professional
• Device Expiration Date: 09/22/2022
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC4040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: Required Intervention