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 Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Embolism/Embolus (4438)

Event Date 06/02/2021

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 could not be conclusively determined.

Event Description

During a left atypical flutter ablation procedure, air embolisms occurred in the patient that caused an st elevation.While ablating in the mitral isthmus, the pumped stopped irrigating due to bubbles noted in the tubing set.When exchanging the tubing set, the device was not retrieved from the patient and the irrigation was still turned on from the tubing set as the wrong tube was turned off, so air bubbles went into the coronary arteries and created an st elevation on the electrocardiogram.A coronary sheath was inserted through the aorta in addition to contrast injection and it was possible to successfully flush the air bubbles out and resolve the st elevation.The procedure was not continued and the patient was noted to be stable.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11998641
• MDR Text Key: 256171319
• Report Number: 2030404-2021-00039
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060019
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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: 06/02/2021
• 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): Required Intervention