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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation atrial flutter procedure, the cool point pump was noted to be damage which resulted in cancellation of the procedure.It was not possible to squeeze the tubing set enough to correctly pump.The ablation catheter was changed to a non-irrigated catheter, however no ablation occurred so the procedure was not completed.It was found a screw from the plastic cover/hinge mechanism had dislodged and prevented the cool point pump from working properly.The screw was put back in place and the issue was resolved.
Additional Manufacturer Narrative
Corrected data.
Additional 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 determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17025422
• Report Number: 2030404-2023-00034
• Device Sequence Number: 15185585
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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: 6845729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 06/12/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/16/2023; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male