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

Model Number	402841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/04/2019
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 an atrial fibrillation ablation procedure a cardiac perforation occurred.Following ablation of the cavo-tricuspid isthmus line with a safire ablation catheter, a contact force catheter was used to ablate the pulmonary veins (pvs).While ablating the pvs, the grams of force was intermittently displayed and the fti values were not displayed at all.The catheter was exchanged to resolve the issue when a cardiac perforation was noted.Transesophageal echocardiography confirmed the perforation to be on the right side of the heart where the first ablation catheter was used.A pericardiocentesis was performed to stabilize the patient.The ablation procedure was not continued.There were no performance issues alleged against the first ablation catheter.
Additional Manufacturer Narrative
One safire tx ablation catheter was received for evaluation.The catheter deflected when actuating the steering mechanism and deflected in the correct shape according to specifications.The catheter met specifications for temperature response and electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported cardiac perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8545641
• Report Number: 2030404-2019-00027
• Device Sequence Number: 14064426
• Product Code: OAD
• UDI-Device Identifier: 05414734300179
• UDI-Public: 05414734300179
• 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): 05/13/2019

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: 09/30/2021
• Device Model Number: 402841
• Device Catalogue Number: 402841
• Device Lot Number: 6707648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/13/2019
• 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: Required Intervention
• Patient Weight: 80