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

Model Number	H700488
Medical Device Problem Codes	Device Emits Odor (1425); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a re-do atrial fibrillation procedure, a procedure delay occurred.The ampere suddenly shutdown while tachycardia was induced after ablation a burning smell was noted from the ampere.The power cable was replaced, but the issue persisted.The procedure was delayed one hour until a replacement unit was able to be found and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One ampere¿ rf ablation generator was received into the lab for analysis.An inspection of all internal components was performed prior to testing due to the field reported issue.Ac power was then applied to returned device which failed to initialize, confirming the reported electrical issue.No discolored internal components were observed, and no odors were noted.Additional troubleshooting isolated the root cause to abnormal functionality of the power supply and rf/mn printed circuit boards.Based on the information provided to abbott and the investigation performed, the reported event was confirmed and the root cause of the field reported issue was isolated to abnormal functionality of the power supply and radio frequency/ mn boards.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.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12553634
• Report Number: 2184149-2021-00273
• Device Sequence Number: 19156374
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 5509649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 09/07/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2016
• 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