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

Model Number	H700488
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 2184149-2022-00104, 2184149-2022-00105.During an atrioventricular nodal reentrant case, the user switched from cryo to rf and received a 999-impedance error on the generator.Patch placement was confirmed and replaced with good communication between the generator and amplifier.The cables were inspected, reseated, rebooted the amplifier, generator, tactisys and the dws which did not resolve the issue.The catheter was replaced with one from a different lot and attempted a second se port, but the issue remained.The case continued by switching back to cryo with no patient harm.
Additional Manufacturer Narrative
One ampere¿ rf ablation generator was received for evaluation.Evaluation of the logs revealed an ¿lag processing 1 notifications for cycle¿ which confirms the reported symptom.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the investigation and information provided to abbott, this symptom was not able to be duplicated, however, the root cause is attributed to software design.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• 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: 14118078
• Report Number: 2184149-2022-00103
• Device Sequence Number: 2276962
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 4798977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• 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: 03/28/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE X EP SYSTEM AMPLIFIER; TACTISYS¿ QUARTZ ABLATION SYSTEM
• Patient Sex: Unknown