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

Model Number 402808

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 01/13/2020

Event Type  Injury  

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 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 Description

The catheter moving out of positive was caused by the handling of the catheter.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9695981
• MDR Text Key: 178766017
• Report Number: 2182269-2020-00012
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05414734205993
• UDI-Public: 05414734205993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960016-S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 02/16/2020
• Supplement Dates FDA Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR