MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-D
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: (b)(4).During a supraventricular tachycardia procedure, there were communication and temperature issues with two flexability catheters, and performance issues with the ensite x system, resulting in a delay of procedure.At first navx was being used, however the patient had a fat from the crista terminalis.Therefore, the mode was switched to voxel.The flexability se being used was switched to a tactiflex due to technical issues and used for mapping in voxel mode, while using the supreme and cs catheter for mapping in navx mode.The following issues occurred with the ensite x system: 1.There were issues with field scaling in navx mode.Navx field scaling and se field scaling were attempted, but neither worked correctly.A lot of points were deleted, which might have been related to point collection in the sheath.2.It was desired to use the flexability se catheter for mapping in navx mode, when it was noticed that the patient had a fat.The flexability se catheter never became a green icon and showed poor sensor quality.The cable was replaced, which did not help.The flexability se catheter was then changed to a new flexability se catheter, where the icon turned green and sensor quality was good.3.The second flexability se gave a continuous temperature alarm, when ablation was started in voxel mode.The flexability se catheter was then exchanged for a tactiflex se, which worked well.4.In navx mode our hd grid showed poor sensor quality.Changing the cable and field frame did not resolve the issue.All patent reference sensors were green.5.The prsa was checked and was in the recommend low sternal position.It was moved to a higher plane sternal position before starting a voxel procedure and then the hd grid showed a green icon.6.The hd grid was in low confidence and collecting false space.7.There was respiration related catheter movement, causing false space.Using "end expiratory triggering" helped, but did not solve the issue completely.8.Editing the model and collecting a complex map needed manual editing, which takes time and is often not possible in a complex procedure under conscious sedation.9.Respiration compensation did not work as needed in such a patient with continuous changing breathing pattern.The system was collecting false space, related to the positional influence of the respiration pattern on catheter localization.10.It took time to switch from navx to voxel mode.The procedure was successfully completed with no adverse consequences.
Additional Manufacturer Narrative
One quadripolar, uni-directional, curve d, flexability sensor enabled ablation catheter was received for evaluation.The catheter met specifications for electrical and temperature testing, and functioned per requirements during an irrigation flow test.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported temperature and communication issues remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• 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: 15925663
• Report Number: 3008452825-2022-00717
• Device Sequence Number: 15051082
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: 05415067020031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/18/2023

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 Expiration Date: 07/31/2025
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 8599043
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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: ENSITE¿ X SOFTWARE.; FLEXABILITY¿ ABLATION CATHETER SE.
• Patient Sex: Unknown