MAUDE Adverse Event Report: ST. JUDE MEDICAL COOL POINT¿ IRRIGATION PUMP TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 85785

Device Problems Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident remains unknown.

Event Description

During a procedure, air was flushed through the cool point pump tubing set and into a patient's left atrium via the tacticath se ablation catheter.The bag of fluid ran out after ablation and air was detected at the pump's bubble detector.After spiking a new bag, there was still a column of air in the tubing that needed to be cleared.When going to flush the air through the tubing, it was checked that there was no contact with the patient.After this was confirmed, the cool point pump was flushed.However, there were two cool point pumps connected to the catheters; one to the tacticath se ablation catheter, the other to the advisor hd grid catheter.The incorrect stopcock on the field was turned off to the patient to flush air from the tubing, and this was not noticed until air had made its way through the cool point pump and into the tacticath se ablation catheter.Air was confirmed to be in the patient as there was an immediate st segment elevation and a pressure drop noted.An urgent cath was done with no air visible in the coronaries, therefore no intervention was done.The patient stabilized after the cath, was extubated, taken to icu, and is doing fine.

Manufacturer Narrative

Corrected information: g3, h2, h6 manufacturer narrative: the results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident remains unknown.

• Brand Name: COOL POINT¿ IRRIGATION PUMP TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17372179
• MDR Text Key: 319551762
• Report Number: 2030404-2023-00041
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85785
• Device Catalogue Number: 85785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• 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): Other
• Patient Age: 69 YR
• Patient Sex: Male