MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL POINT¿ 1779 CABLE (PUMP TO GENERATOR); CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	IBI-85786
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a pvc procedure, it was noted that the cool point pump stopped when ablation was discharged which resulted in procedural delays.The pump was restarted, the radio frequency instrument was restarted, and the pump was changed but the issue was not resolved.The pump cable was exchanged and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6 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.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
Follow up report needed to include corrected device model information.

• Brand Name: COOL POINT¿ 1779 CABLE (PUMP TO GENERATOR)
• 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
• 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: 16484900
• Report Number: 2030404-2023-00014
• Device Sequence Number: 20248847
• Product Code: OAD
• UDI-Device Identifier: 05414734309080
• UDI-Public: 05414734309080
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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-85786
• Device Catalogue Number: IBI-85786
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 10/04/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/27/2023; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown