MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE AORTIC OCCLUSION CATHETER; LEMAITRE OCCLUSION CATHETER

Catalog Number OLC1050

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

We have not yet received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the incident.Our review of the lot history records for this lot number 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 number.Catheter was used in a cadaver in order to remove the liver, kidneys and pancreas for transplant.Device operated properly during pre-use check and during initial phase of the procedure.It is possible that the balloon ruptured due to calcification on the aortic walls.

Event Description

A (b)(6) cadaver was put into ecmo with nonmothermic reperfusion in order to remove the liver, kidney and pancreas for transplant.The aortic balloon was channeled through the left femoral artery and was inflated to 30 cc with 0.9% saline.Radial blood pressure drop was verified confirming the catheter was functioning properly.During the procedure, ecmo stopped and it went to an asystole in less that 2 minutes.Transplant coordinator then infused saline to a maximum dose of 50 cc without experiencing any resistance.Ecmo was activated again and resumes self-resuscitation.However, ecmo stopped again.So, the procedure was suspended and the balloon was removed from the patient's vessel.He observed that the balloon of this catheter had ruptured.

• Brand Name: LEMAITRE AORTIC OCCLUSION CATHETER
• Type of Device: LEMAITRE OCCLUSION 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: 9504109
• MDR Text Key: 187777392
• Report Number: 1220948-2019-00170
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101658
• UDI-Public: 00840663101658
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132022
• 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: 12/19/2019

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 Expiration Date: 01/28/2024
• Device Catalogue Number: OLC1050
• Device Lot Number: 2107-81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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): Other
• Patient Age: 46 YR