MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturing reference: 3008452825-2019-00358, 2182269-2019-00100, 3008452825-2019-00359, 2030404-2019-00058.During a pulmonary vein contraction (pvc) ablation procedure a pericardial effusion occurred.Following ablation of the right coronary cusp, the user attempted a second pvc in the left ventricle (lv) through the coronary sinus (cs).A flexability catheter was used first through an agilis sheath but there was no success in reaching the target site.A safire catheter was then attempted but it was decided the anatomy of the patient was too difficult to place a catheter out distally in the cs.The user decided to forgo further ablation and proceeded with an ep study.During the ep study the patient became hypotensive and echocardiography confirmed fluid in the pericardium necessitating a pericardiocentesis.Once stabilized the patient was transferred out of the or.There were no performance issues with any abbott device.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8821457
• Report Number: 2182269-2019-00099
• Device Sequence Number: 2348675
• Product Code: LPB
• UDI-Device Identifier: 05414734206013
• UDI-Public: 05414734206013
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P960016
• 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
• Report Date (Section B): 07/24/2019

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: 02/28/2022
• Device Model Number: 402810
• Device Catalogue Number: 402810
• Device Lot Number: 6899314
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/24/2019
• 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: AGILIS¿ NXT STEERABLE INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 109