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

Model Number AFD0178

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Related manufacturer report number: 2184149-2023-00043.During the atrial fibrillation procedure, communication issues with the ampere and the cool point pump resulted in the procedure being cancelled.It was noted there was a "pump not connected" error.The cool point pump was reconnected, cable power cycled and there was still an error.The case was ultimately aborted after five ablation lesions, due to issues with ampere and irrigation pump.There were no adverse consequences to the patient.

Manufacturer Narrative

One cool point irrigation pump was received for complaint evaluation.During the functional testing the pump functioned as intended.No error or defect was noted during the entire testing.The pump door screws were loose, and the pump door was loose as well.During the functional testing the pump functioned as intended.No error or defect was noted during the entire testing.During repair, the pump door assembly was adjusted and the bumper rounds were replaced.

Manufacturer Narrative

Corrected data.

• Brand Name: COOL POINT¿ IRRIGATION PUMP
• Type of Device: 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: 16454517
• MDR Text Key: 310426103
• Report Number: 2030404-2023-00011
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFD0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AMPERE¿ RF ABLATION GENERATOR.