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

Model Number H700489

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Event Description

During an atrioventricular nodal reentrant tachycardia case, there was a delay due to the ampere rf generator.The tacticath df ablation catheter was positioned at the location of the slow pathway and as soon as the power on button was pressed for ablation, an alarm sounded saying impedance out of range.This was despite the impedance displaying a value of only 130 ohms.Connections to the ampere rf generator were confirmed and the auto flow settings were reset as they had reverted to the default.Ablation was attempted again with the same outcome.A replacement ground was used to resolve the issue but again even though the impedance was below the 150 ohm setting, no ablation could be delivered.A flexability se catheter was then connected to the ampere rf generator, using a different ablation extension cable.Again, the impedance was registering below the impedance cutoff of 150 ohms, but ablation could not be delivered because of the impedance issue.It was suggested to reboot the ampere rf generator which had been done previously but it was also asked which ablation ground was connected to the patient and ampere rf generator.It was a non-abbott device (conmed 410-2000) which was said to not be compatible with the ampere rf generator.However, this ground had been used for the last 18 months.A competitive ablation catheter with the stockert rf generator was used in order to complete the case successfully.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for evaluation.The reported event was confirmed by reviewing the log files.Based on the information and investigation provided to abbott, the root cause was isolate to software design.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.A capa is related to this complaint investigation.The issue will continue to be monitored for trends and reviewed in qdr (quality data review).

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18691139
• MDR Text Key: 335313542
• Report Number: 2184149-2024-00028
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05415067004895
• UDI-Public: (01)05415067004895(10)4995065
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700489
• Device Lot Number: 4995065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1