MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL POINT¿ IRRIGATION PUMP PRESSURE ADAPTER CABLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	H701666
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was a pressure error that would not resolve resulting in cancellation of the procedure.The pressure error would intermittently resolve itself by manipulating the pressure adapter cable.There were no adverse patient consequences.The cable was replaced to resolve the issue.
Additional Manufacturer Narrative
Additional information: d9, g2, h2, h3 one cool point pressure adapter cable was received for evaluation.The reported pres error was confirmed.Further investigation concluded that the red conductor wire was fractured in the connector plug, consistent with the reported pressure error.The cause of the fractured conductor wire remains unknown.
Additional Manufacturer Narrative
Corrected information: b5, d4, g1, g3, h2, h11.The model number was updated to h701666.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
During an atrial fibrillation procedure, there was a pressure error that would not resolve resulting in cancellation of the procedure.The pressure error would intermittently resolve itself by manipulating the pressure adapter cable.There were no adverse patient consequences.The cable was replaced to resolve the issue.The model number was updated to h701666.

• Brand Name: COOL POINT¿ IRRIGATION PUMP PRESSURE ADAPTER CABLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15128853
• Report Number: 2030404-2022-00054
• Device Sequence Number: 6604337
• Product Code: OAD
• UDI-Device Identifier: 05415067016669
• UDI-Public: 05415067016669
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/05/2024

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: H701666
• Device Catalogue Number: H701666
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 10/10/2024
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/25/2022; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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