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

Model Number	IBI-89003
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure a pressure sensor error was displayed on the pump, which could not be cleared and ablation could not be performed.The patient was already prepped and had catheters in place when the procedure was cancelled.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One cool point irrigation pump was received for evaluation.After power up, the pump passed the self-start-up test.Once a cool point tubing set from the current inventory was inserted into the returned cool point pump and primed a ¿bubd¿ alarm was displayed upon pressing the arrow key to start the flow rate test.No bubbles were detected from the tubing set.Cleaning the bubble detector and reconnecting the tubing set to the device did not clear the ¿bubd¿ alarm.Therefore, testing was discontinued and the reported ¿pres¿ alarm could not be determined.The faulty bubble detectors were replaced and the pump functioned as intended.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with manufacturing specifications and procedures.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with manufacturing specifications and procedures.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: COOL POINT¿ IRRIGATION PUMP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7985728
• Report Number: 2030404-2018-00071
• Device Sequence Number: 221834
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P060019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBI-89003
• Device Catalogue Number: IBI-89003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 01/02/2019
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/03/2018; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1