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

Model Number H700488

Device Problems No Display/Image (1183); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure, the generator screen turned black and connection was lost between the generator and the remote control and irrigation pump.Troubleshooting included changing the power source and power cables, reseating all connections, cleaning the vent holes, and power cycling the generator, but the issue remained.As ablation could not be performed, the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6.One ampere¿ rf ablation generator was received for analysis.Visual inspection of the returned generator confirmed all connectors, switches, and labels appeared to have no physical damage.All the mounting hardware was secured.Normal wear from use was observed on the exterior chassis.Ac power was applied to the returned ampere generator and the unit failed to power up, no boot sequence was observed.Checked the fuses and no problem was found with the fuses.Temporarily replaced the power supply board with a known good board assembly & power was reapplied to the system, upon which a normal boot sequence was observed & normal function was restored to the unit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, root cause of the field reported event citing the unit would not power on was successfully isolated to a system level component on the power supply unit.

• 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: 10355312
• MDR Text Key: 201506323
• Report Number: 2184149-2020-00114
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other