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

Model Number 85784

Device Problems Improper or Incorrect Procedure or Method (2017); Output Problem (3005); Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 03/22/2022

Event Type  Injury  

Event Description

During the procedure, the ablation fluid bag emptied and the system alarmed.A new bag was hung, however there was a possibility that when switching the bags, the patient received an air bolus, despite bleeding the line.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number/batch number of the device was unavailable.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: COOL POINT ¿ IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 14274440
• MDR Text Key: 290775568
• Report Number: 2030404-2022-00036
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85784
• Device Catalogue Number: 85784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other