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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Arrhythmia (1721)

Event Date 01/18/2024

Event Type  Injury  

Event Description

During an ablation procedure, an air embolism occurred resulting in an arrhythmia and requiring a coronary angiogram and medication administration to stabilize the patient.At the end of the procedure, the infusion bag was noted to be empty.A new infusion bag was connected and a request was made to the physician to withdraw the ablation catheter from the patient to prime the tubing.The physician declined stating the three-way stopcock was closed to the patient.While priming, it was noted that fluid was not dripping from the open port on the stop-cock and the physician was notified.The physician checked the line and stated the air entered the catheter and into the patient.The patient experienced bradycardia and st segment elevation.Coronary angiography was performed and atropine along with other medications were administered to stabilize the patient.The veins were checked with the mapping catheter and the procedure was completed.The physician reports that no abbott device is at fault for this event.The cool point pump was used during the procedure and the bubble alarm was functioning.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The cool point pump operator manual states ¿do not prime the catheter while it is in the patient¿.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 issue is consistent with the incorrect use of the device.

• 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, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18651286
• MDR Text Key: 334662628
• Report Number: 2030404-2024-00010
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• 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): Life Threatening; Required Intervention