MAUDE Adverse Event Report: ABBOTT MEDICAL 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial flutter (afl) and avnrt procedure, pressure issues resulted in the procedure being cancelled.A continuous pressure error was noted.The tubing set was replaced twice, and the adaptor was taken off the front of the device and plugged directly into the pump, but the issue persisted.The pressure adapter was also replaced with no resolution.The afl part of the procedure was completed using the non-abbott pfa system (boston scientific pfa system), but the patient will have to return to complete the avnrt procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One cool point irrigation pump was received for evaluation.The reported pressure issues and continuous pressure error could not be confirmed.A cool point tubing set from current inventory was inserted into the returned cool point pump.During the functional testing fluid flowed through the tubing set with no functional anomalies noted.The flow rate was within the specification.No functional errors or ¿pres¿ alarm was noted during entire testing of the pump.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.

• Brand Name: COOL POINT¿ IRRIGATION PUMP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24634639
• Report Number: 2030404-2026-00016
• Device Sequence Number: 15627676
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: (01)05415067008985(10)10581663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 03/25/2026

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: 10581663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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