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

Model Number	85784
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 2184149-2019-00220, 3008452825-2019-00574, 3005334138-2019-00629.During a procedure, the diagnostic catheters and their respective signals displayed as expected on the ensite system.When the ablation catheter was connected, the cool point pump functioned as expected and the calibration of the contact force measurement was conducted successfully.When the ablation catheter was inserted into the patient, the distal electrode and m3 were not recognized and was distorted on ensite.The connections were checked and validated, ensuring proper connection.The catheter was exchanged for another tacticath se and the same issue occurred.It was also not possible to perform the calibration of the contact force for the catheter.A pressure error was also noted on the cool point pump.Another mapping system was used to complete the procedure and there were no adverse consequences to the patient.There was approximately a 45 minute delay in the procedure which was clinically significant.
Additional Manufacturer Narrative
One cool point ¿ irrigation pump was received for investigation.The pump passed the self start up test.During the functional test, fluid flowed through the tubing set with no functional anomalies noted.The pump met specifications during flow testing and no errors or other functional anomalies were noted.The device met specifications prior to release from abbott manufacturing facilities as supported by the device history record.The cause of the reported ¿pres¿ error and subsequent cancellation remains unknown.
Additional Manufacturer Narrative
Additional information: g4, g7, h2, h10.Corrected information: e1.

• Brand Name: COOL POINT ¿ IRRIGATION PUMP
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 9325400
• Report Number: 2030404-2019-00111
• Device Sequence Number: 19394011
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 85784
• Device Catalogue Number: IBI-89003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 02/26/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/12/2019; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPERE¿ RF GENERATOR II.; TACTICATH¿ CONTACT FORCE CATHETER, SE (X2).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 54