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

Model Number	H700494
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, high impedance was noted which caused a delay.High impedance was noted on the catheter before rf.When ablation started, a high impedance error occurred.The ablation catheter and grounding pads were exchanged which did not resolved the issue.Additionally, the tactisys to ampere rf cable was replaced but the issue persisted.The ampere generator was replaced to complete the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One ampere generator was received for analysis.The device was powered on and booted up successfully.The device was run through a functional test and functioned as anticipated.The log files on the unit from the reported date were reviewed and confirmed instances of impedance out of range errors, 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.Based on the information provided to abbott and the investigation performed, root cause of the reported impedance issue and subsequent delay could not be determined as the returned generator functioned as anticipated.

• 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: 17039747
• Report Number: 2184149-2023-00114
• Device Sequence Number: 6459108
• Product Code: LPB
• UDI-Device Identifier: 05415067004949
• UDI-Public: 05415067004949
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/15/2023

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: 6006300
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• 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