MAUDE Adverse Event Report: ST. JUDE MEDICAL THERAPY¿ ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	IBI-83366
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer ref# 2030404-2022-00022.During an atrioventricular nodal reentrant tachycardia ablation, the first ablation catheter was shaped and maneuvered in the target zone and the impedance was over 200 ohms.After raising the impedance limit of the generator, therapy was delivered, however, the tachycardia was unable to be treated.The device was replaced, but the issue remained and rf therapy was abandoned.The procedure was completed using a third catheter.
Additional Manufacturer Narrative
One quadripolar, therapy ablation catheter was received for evaluation.The catheter and the thermocouples met specifications for electrical testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported impedance and rf delivery issues and subsequent delay remains unknown.

• Brand Name: THERAPY¿ ABLATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13873698
• Report Number: 2030404-2022-00021
• Device Sequence Number: 4715982
• Product Code: LPB
• UDI-Device Identifier: 05414734306935
• UDI-Public: 05414734306935
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040014
• 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): 04/29/2022

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 Expiration Date: 12/31/2022
• Device Model Number: IBI-83366
• Device Catalogue Number: IBI-83366
• Device Lot Number: 7330692
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown