MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of heart block was reported.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 heart block could not be conclusively determined.
Event or Problem Description
Related manufacturer reference: 2184149-2020-00017.During a slow pathway modification for an av-nodal reentrant tachycardia (avnrt), heart block occurred.After an rf session was being delivered, it was noticed the catheter jumped out of position and the generator was requested to be called off.The rf was not ceased until 4-5 seconds after the request.Av block occurred due to the delayed response in turning off the generator.The patient required a permanent pacemaker implant and was in a stable condition.
Event or Problem Description
The catheter moving out of positive was caused by the handling of the catheter.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9695981
• Report Number: 2182269-2020-00012
• Device Sequence Number: 1878090
• Product Code: LPB
• UDI-Device Identifier: 05414734205993
• UDI-Public: 05414734205993
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960016-S014
• 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): 02/17/2020

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: 05/31/2020
• Device Model Number: 402808
• Device Catalogue Number: 402808
• Device Lot Number: 5997931
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/16/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 02/17/2020
• 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: Required Intervention
• Patient Age: 70 YR