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

Model Number A-FASE-DF

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Stroke/CVA (1770)

Event Date 03/06/2024

Event Type  Injury  

Event Description

During the pulmonary vein isolation (pvi) procedure, the patient experienced a stroke.The cavo-tricuspid isthmus, pulmonary vein isolation, roof linear line, vein of marshall were performed in sequence, and finally, peri-mitral isthmus (pmi) ablation was performed.While attempting the pmi ablation near the annulus, a high temperature and high impedance alarm was noted (above 180, ablation #46, during ablations #46-50 impedance of 220-240).The cable was exchanged, and another grounding patch was applied.Upon checking the isolation of the pvi, an alarm indicating high impedance was noted, which was attributed to the presence of a pouch near the vein (anterior roof side).The alarm continued so the catheter was removed from the patient and char was noted at the tip of the catheter.Immediately after the char was confirmed that patient was transferred to the intensive care unit and an mri and ct scan were performed.The day after the procedure, the patient displayed a "drowsy condition" due to stroke (multi-infarction) and the patient's condition has remained the same.

Manufacturer Narrative

Four images were submitted for evaluation, no product was received.The returned images appeared to show char on the catheter tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the char on the catheter tip could not be conclusively determined.

Event Description

Follow up report needed to include updated device information.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER
• Type of Device: 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: 18891573
• MDR Text Key: 337509368
• Report Number: 3008452825-2024-00139
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: (01)05415067020062(10)10100321(17)261031
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-FASE-DF
• Device Lot Number: 10100321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening