MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701157
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3008452825-2022-00596.During a premature ventricular contraction procedure (pvc), two ablation catheters showed abnormal impedance and signal interference which caused a delay.While using the tacticath¿ contact force ablation catheter, sensor enabled to discharge the left ventricular outflow tract for 30 seconds, impedance increased from 105 to over 150, accompanied by signal interference and the radiofrequency instrument automatically cut off the discharge.A flexability¿ablation catheter, uni-d was then used which started normally, however, the same issue occurred approximately 15 minutes later.The catheter was replaced again and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
One quadripolar, uni-directional, curve d, flexability ablation catheter was received for evaluation.Electrode 1 met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported impedance issue and subsequent delay remains unknown.

• Brand Name: FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15402024
• Report Number: 3008452825-2022-00597
• Device Sequence Number: 20085384
• Product Code: OAD
• UDI-Device Identifier: 05415067011497
• UDI-Public: 05415067011497
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/08/2022

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: 12/31/2024
• Device Model Number: A701157
• Device Catalogue Number: A701157
• Device Lot Number: 8296943
• 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: 09/04/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Sex: Unknown