MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402151
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
During a paroxysmal supraventricular tachycardia, a steam pop occurred in the right atrium resulting in atrioventricular (av) heart block.Ablation was conducted with the ampere and the power settings were at 55 w using temperature control.At the time of steam pop, the temperature was 52 degrees.The ablation procedure was stopped since the patient developed transient atrioventricular (av) block due to the steam pop.The patient was transferred for observation and sinus rhythm was restored without any intervention.The patient is in stable condition.
Additional Manufacturer Narrative
The event of a steam pop and av block was reported.The catheter met specifications for electrical and temperature testing with no functional anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported steam pop and subsequent av block may have been procedure related.

• Brand Name: LIVEWIRE TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10409674
• Report Number: 2182269-2020-00070
• Device Sequence Number: 11360867
• Product Code: LPB
• UDI-Device Identifier: 05414734200240
• UDI-Public: 05414734200240
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P960016
• 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
• Report Date (Section B): 08/26/2020

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 Expiration Date: 09/30/2022
• Device Model Number: 402151
• Device Catalogue Number: 402151
• Device Lot Number: 7180473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other