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

Catalog Number 1601-38

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

We have not yet received the complaint device for evaluation from the hospital.Hence, at this time, we could not determine the cause of this failure.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.As part of our manufacturing process, a 100% balloon and winding inspection are performed on each of the manufactured product to ensure each catheter operates properly.We have also performed pull test on a sample of units from this lot number during our in-process inspection.All of these units passed the test requirements when the balloons were pull tested to their validated force.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.Our sales rep.And the distributor had reached out to the contact person at the hospital for additional information regarding the incident.However, we have not received any response back from the contact person yet.We have implemented a corrective and preventive action (capa) to address similar issues and prevent them from reoccurring.As part of the capa, we have already made adjustments to the process which should improve the reliability of the ligature windings.

Event Description

During an embolectomy procedure in a popliteal artery, the balloon of the embolectomy catheter dislodged from the catheter shaft and was retained in the patient's blood vessel.Surgeon had to perform additional surgery to retrieve the dislodged balloon.No further information was provided by the surgical team.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 9210120
• MDR Text Key: 178786580
• Report Number: 1220948-2019-00144
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K992368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 1601-38
• Device Lot Number: SLC4814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention