MAUDE Adverse Event Report: ST. JUDE MEDICAL COOL POINT¿ IRRIGATION PUMP TUBING SET; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 85785

Device Problems Improper or Incorrect Procedure or Method (2017); Gas/Air Leak (2946)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Asystole (4442)

Event Date 03/04/2022

Event Type  Injury  

Event Description

During the atrial fibrillation procedure, air aspiration and subsequent stroke occurred.The saline + heparin solution irrigation was replaced.After replacing the irrigation fluid, while flushing air bubbles, the tubing was left open to the patient and the tubing for the sheath was closed which flushed air into the left atrium.The patient went asystolic, and several interventions such as cpr and epinephrine were given.The patient regained normal sinus rhythm and normal vitals and the procedure was continued.Post procedure, it was determined via mri that the patient had a stroke.Air was visualized via ice.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.However, the event description states that when flushing air bubbles after replacing the saline + heparin solution the tubing set was left open to the patient which flushed air into the left atrium, consistent with the reported event.

• Brand Name: COOL POINT¿ IRRIGATION PUMP TUBING SET
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13900607
• MDR Text Key: 287889113
• Report Number: 2030404-2022-00024
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 85785
• Device Catalogue Number: 85785
• Device Lot Number: H2297513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Male