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

Model Number 2100-12

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2020

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 distal bond between the balloon and the catheter shaft.The root cause of the issue was determined to be an operator error- not enough glue was applied on the joint during the assembly process.We have not received any other complaints of a similar nature for devices from this lot.Therefore, we believe that it was an isolated incident.Surgeon detected the malfunction during pre-use check.Device was not used for the procedure.He then used another pruitt aortic occlusion catheter for the procedure.

Event Description

During pre-use check, surgeon observed a leakage at the tip of the balloon when he attempted to inflate the balloon with saline.Device was not used for the procedure.

• Brand Name: PRUITT AORTIC OCCLUSION CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• 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: 9837275
• MDR Text Key: 197796936
• Report Number: 1220948-2020-00034
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: 00840663101511
• UDI-Public: 00840663101511
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K872090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 2100-12
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2015
• 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