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	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, noise was noted on the tacticath distal channel when the pump was flowing and a delay occurred.There was no noise on the proximal channel.The egm cable was swapped out with a spare and the distal channel was reassigned but the issue persisted.The grounding patch was moved and another pump was borrowed which did not resolve the noise issue.It was decided to proceed and use different filters on the ablator distal signal.Changing the tubing, ablation catheter, unplugging the generator, pump, and tactisys did not resolve the issue.The filters and gain were changed on the recording system, the pin of the ablation catheter was connected to different pins on the pinblock and the cable was exchanged which did not resolve the issue.The procedure was completed with no adverse consequences to the patient.The power cords have been plugged into different power sources to mitigate the chances of this happening again.Cases have been performed since this issue with no noise and the hospital continues to use the pump.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported noise and subsequent delay remain unknown.
Additional Manufacturer Narrative
Corrected h6 code: 4604 - delay to treatment/ therapy.

• 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
• 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: 12300033
• Report Number: 2030404-2021-00048
• Device Sequence Number: 14390625
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/24/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: IBI-89003
• Device Catalogue Number: IBI-89003
• Device Lot Number: 6286131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/26/2021; 02/24/2023
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/26/2021; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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