MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AMPERE¿ RF ABLATION GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number H700488

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

The results/method and conclusion codes along with investigation results will be provided in the final report.

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.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported av block could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

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

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9695971
• MDR Text Key: 178766602
• Report Number: 2184149-2020-00017
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700488
• Device Catalogue Number: H700488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR