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

Model Number	H700494
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure with the patient on the table, the generator did not recognize the catheter and the case was cancelled.There were no signals getting to claris or the ensite system.Troubleshooting included, new connecting cables, catheters, power cycling, a new amp to ampere cable with no resolve.The case was cancelled with no consequences to the patient.
Additional Manufacturer Narrative
One ampere¿ rf ablation generator was received for evaluation.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 and the unit completed the post (power on self test) successfully and the screen display came up normally.A load box was connected to the unit and the measured impedances were found to be normal.A catheter connection was simulated, and the unit connected without issue.Test ablations were performed, and the unit functioned normally.The system log files on the unit from the reported event date were reviewed and confirmed multiple instances of connection disconnection messages, however no conclusive abnormalities were identified.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.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.Based on the information provided to abbott and the investigation performed, the reported communication issue and subsequent cancellation remain unknown.

• Brand Name: AMPERE¿ GENERATOR KIT
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15084513
• Report Number: 2184149-2022-00175
• Device Sequence Number: 17157652
• Product Code: LPB
• UDI-Device Identifier: 05415067004949
• UDI-Public: 05415067004949
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H700494
• Device Catalogue Number: H700494
• Device Lot Number: 5143291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown