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	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, impedance issues resulted in the procedure being cancelled.It was noted that there was high impedance (above 150 ohms) during ablation.The rf cables and catheter were exchanged, but the issue persisted and the procedure was cancelled.There are no reported adverse patient consequences.
Additional Manufacturer Narrative
One ampere¿ rf ablation generator was received for evaluation.The product functioned as anticipated during testing with no abnormalities identified that would result in the reported complaint.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 field reported event could not be conclusively determined as the returned ampere generator functioned as anticipated, with no anomalies identified that would result in the reported complaint.

• 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: 16900083
• Report Number: 2184149-2023-00100
• Device Sequence Number: 14817327
• Product Code: LPB
• UDI-Device Identifier: 05415067004949
• UDI-Public: 05415067004949
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/26/2023

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: 4847378
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2014
• 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
• Patient Sex: Male