MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number	402840
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: 2184149-2018-00138.During an atrial ventricular node ablation, the ablation signals and radiofrequency data were unable to be seen from the ampere generator and the procedure was cancelled.The cables were reconnected, the generator selection was verified, and the patches were confirmed to be connected to the patient with no resolution.The procedure was cancelled.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The catheter met specifications for electrical testing and no functional anomalies were noted during the ablation simulation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal, rf data display issue, and subsequent procedure cancellation remains unknown.

• Brand Name: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT
• Common Device Name: CATHETER, PERCUTANEOUS CARDIAC ABLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7819776
• Report Number: 2030404-2018-00064
• Device Sequence Number: 2447126
• Product Code: OAD
• UDI-Device Identifier: 05414734300162
• UDI-Public: 05414734300162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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 Expiration Date: 04/30/2021
• Device Model Number: 402840
• Device Catalogue Number: 402840
• Device Lot Number: 6458647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: WORKMATE CLARIS SYSTEM; WORKMATE¿ CLARIS¿ SYSTEM
• Outcome Attributed to Adverse Event: Other