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

Catalog Number 1651-48

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

We have not received the complaint device for evaluation.However, we were able to observe the reported incident on the picture that was provided to us.The balloon of the over-the-wire catheter was missing in its lumen.In the picture, we did not observe any catheter lumen separation or necking.The balloon of the over-the-wire embolectomy catheter was used to remove an old thrombus.The patient was previously operated two years before and had a xenosure patch implanted in his groin area.As is common with other catheterization procedures, complications including tip separation may occur during use of embolectomy catheters.Our ifu properly identifies the risks associated with the use of these embolectomy catheter to its users.To minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.Based on the reported incident, it is likely patient's anatomical features( stenotic anastomosis ) together with procedural factors ( use of excessive force to remove the thrombus ) may have contributed to the balloon separation as the surgeon attempted to pull the balloon and the thrombus from this narrowed region of the blood vessel.There was no injury to the patient as the result of this incident.Surgeon used another embolectomy catheter ( from a different manufacturer ) to remove the thrombus and the dislodged balloon.

Event Description

During thrombectomy of a ptfe graft, surgeon initially inserted a lemaitre single lumen embolectomy catheter to remove an old thrombus from the patient's femoral artery.However, he could not get the catheter past the thrombus.Using a guidewire, he was able to insert a lemaitre over-the-wire embolectomy catheter past the thrombus.When pulling the thrombus, surgeon experienced strong resistance at the anastomotic area between the artery and ptfe.So, he exerted greater pull force to remove the thrombus.By doing so, he was able to remove the catheter.However, the catheter was missing the balloon.He then used another embolectomy catheter ( from a different manufacturer ) to remove the thrombus and the dislodged balloon.There was no injury to the patient as the result of this incident.

• 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: 9350808
• MDR Text Key: 170681199
• Report Number: 1220948-2019-00153
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100682
• UDI-Public: 00840663100682
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K022145
• 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: 11/20/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1651-48
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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