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

Catalog Number UNKNOWN

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the failure.During the phone conversation with the radiologist, he stated that the balloon was over-inflated to 1.5 ml by the operating surgeon which could have resulted in the balloon burst.He also tentatively stated that the burst resulted in the vessel injury.We have reached out to the radiologist multiple times for additional information.The radiologist stated that an internal investigation had been initiated at the hospital and he could not disclose any further information until the investigation is complete.At this time, we could not conclusively determine the root cause of the event.However, it is possible that the balloon rupture resulted due to user error since the operating surgeon overinflated the balloon to 1.5 ml against our recommended maximum inflation volume of 0.75 ml for the 4fr embolectomy catheter.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque and overinflated balloon.To minimize the risk of vessel damage or balloon rupture, 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 ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.

Event Description

Radiologist stated that during an embolectomy procedure, the balloon of a lemaitre embolectomy catheter burst in the popliteal artery of a patient.He also tentatively stated that the balloon burst resulted in a vessel injury.It could not be confirmed if the catheter that was used for the procedure was an over-the-wire embolectomy catheter or a single lumen embolectomy catheter.

• Brand Name: LEMAITRE EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 9656030
• MDR Text Key: 177380366
• Report Number: 1220948-2020-00014
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2020

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/31/2020
• 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