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

Model Number 2100-12

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.When we attempted to inflate the balloon with saline, we observed a leakage at the white stopcock.Upon further inspection of the joint, we observed an inadequate amount of glue at the stopcock joint.The root cause of the issue was determined to be an operator error- not enough glue was applied on the stopcock joint during the assembly process.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.We currently have a corrective and preventive action (capa) open to address this issue and prevent them from reoccurring.There was no injury to the patient as the result of this malfunction.Surgeon used another pruitt aortic occlusion catheter and continued the procedure.

Event Description

Pruitt aortic occlusion catheter was used for occluding aorta during abdominal aortic aneurysm repair (aaa).Soon after occluding the artery with the inflated balloon of the occlusion catheter, surgeon observed saline leakage from the white stopcock deflating the balloon.There was no injury to the patient as the result of the device malfunction surgeon used another pruitt aortic occlusion catheter and continued the procedure.

• Brand Name: PRUITT AORTIC OCCLUSION CATHETER
• Type of Device: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, ma ; 2212266152
• MDR Report Key: 9859553
• MDR Text Key: 190111576
• Report Number: 1220948-2020-00037
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: 00840663101511
• UDI-Public: 00840663101511
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K872090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 2100-12
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention