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

Model Number	IBI-89003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cool point irrigation pump was received for complaint evaluation.After power up, the pump passed the self-start-up test.A cool point tubing set from the current inventory was inserted into the returned cool point pump.The tubing set was primed and fluid flowed through the tubing set.A ¿bubd¿ alarm was displayed upon pressing the arrow key to start the flow rate test.No bubbles were detected from the tubing set.Therefore, the testing was discontinued.During servicing the ¿bubd¿ detectors were found to defective and the defective ¿bubd¿ detectors were replaced.After that the pump functioned normally.The device met specifications prior to release from abbott manufacturing facilities as supported by the device history record.
Event or Problem Description
During a supraventricular tachycardia ablation procedure, the pump wheel would not turn and due to having to borrow a replacement pump from a different hospital during the procedure, a prolonged procedure occurred.The procedure was able to be successfully completed with the replacement pump with no adverse consequences to the patient.

• Brand Name: COOL POINT IRRIGATION PUMP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 12341699
• Report Number: 2030404-2021-00052
• Device Sequence Number: 17128283
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P060019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBI-89003
• Device Catalogue Number: IBI-89003
• Device Lot Number: 4911947
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1