MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. OVER-THE-WIRE EMBOLECTOMY CATHETER

Catalog Number 1651-84

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation since the device has been discarded by the user at the hospital.However, we were able to confirm the reported incident based on the pictures of the malfunction provided to us by the surgical team.We observed that the balloon and the markers were missing from its catheter shaft.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.According to the imaging operations manager at the hospital, the radiologist first used a different balloon for the fistuloplasty to stretch the blood vessels.He then used lemaitre over-the-wire embolectomy catheter to pull out the clot.At the end of the case, he experienced difficulty deflating the balloon completely even after multiple attempts.With some resistance, he was able to remove the balloon/catheter through the sheath.During the next post run with contrast to verify vessel patency, the balloon and two radiopaque markers were identified inside the vein.The radiologist attempted to retrieve the dislodged balloon and the radiopaque markers but was unsuccessful.Surgical team expect the dislodged parts to remain stationary in his collateral vessel of the subclavian vein based on the physician's effort to remove those parts and the patient's history of chronic central clot and his existing collateral anatomy in this area.Based on our investigation and the picture of the catheter provided to us, it is possible that the proximal ligature slipped during the procedure preventing the balloon to deflate completely.The slippage of ligature could have occurred due to the patient's anatomical ( occlusion of subclavian and brachial vein, chronic clot) or procedural factors ( use of excessive force to remove the clot ).However, when the radiologist attempted to remove the partially inflated balloon through the sheath, it could have resulted in complete dislodgement of the balloon and the markers from its catheter shaft.However, without the returned device, we are inconclusive about the root cause of this incident.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.Despitre being inconclusive about the root cause of this incident, we have opened a corrective and preventive action (capa) to investigate the potential root causes of this issue and to minimize the occurrence of these issues in future.This capa remains an active project at this time.The patient has been discharged from the hospital.

Event Description

Ater completion of a fistuloplasty case, the radiologist was not able to completely deflate the balloon even after multiple attempts while trying to remove the catheter from the sheath.With slight resistance, he was able to remove the catheter through the sheath.During the next post run with contrast to verify vessel patency, the balloon and two radiopaque markers were identified inside the vein.The radiologist attempted to retrieve the dislodged balloon and the radiopaque markers but was unsuccessful.Due to patient history of chronic subclavian and brachial vein occlusions, the patient has multiple collateral vessels.The dislodged balloon and markers were suspected to have lodged into a collateral vessel of the subclavian vein.

• Brand Name: OVER-THE-WIRE 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: 8875040
• MDR Text Key: 178779195
• Report Number: 1220948-2019-00098
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2019

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: 1651-84
• Device Lot Number: OTW3979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2018
• 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