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

Model Number IBI-89003

Device Problem Unexpected Shutdown (4019)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

During the premature ventricular contractions procedure, the cool point pump would unintentionally power off and needed to be restarted 6-8 times during the procedure resulting in a delay.The catheter was exchanged with a safire 4mm dry tip ablation catheter until another cool point pump could be used.The dry tip rf lesions were reinforced with the tacticath se ablation catheter with irrigation using a spare cool point pump.The procedure was successfully completed with no patient consequences.

Manufacturer Narrative

One cool point irrigation pump was received for complaint evaluation.The pump functioned normally during the functional testing and the servicing.No issue was observed.The pump was left running for half an hour, the power did not off.The device met specifications prior to release from abbott manufacturing facilities as supported by the device history record.

• Brand Name: COOL POINT¿ IRRIGATION PUMP
• Type of Device: 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: 15639165
• MDR Text Key: 304720095
• Report Number: 2030404-2022-00065
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• 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
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBI-89003
• Device Catalogue Number: IBI-89003
• Device Lot Number: 7492631
• 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: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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