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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Arrhythmia (1721); Nerve Damage (1979); Cardiac Perforation (2513); Heart Block (4444); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The following was published in the journal of arrhythmia, supplement 1 39 :171.John wiley and sons inc.(jan 2023) in an article titled "using computed tomogram atrial myocardial thickness maps in high-power short-duration radiofrequency pulmonary vein isolation", taehyun hwang; op-046-af (track 6 -af7) a study of 200 patients was conducted.The efficacy and safety of pv antral wt-guided hpsd rf-pvi by titrating the duration of 60 w energy delivery to each point.Based on our previous studies and experience, 15 seconds of 60 w hpsd using flexability was considered the control treatment.We compared the control treatment with the wt-guided ablation, which reduces rf delivery time in the thin lawt areas, in this prospective single-center randomized clinical trial.We measured and utilized lawt using automated customized software (amber, laonmed, korea) in real-time during afca procedures.Tamponade occurred in 11 patients, hemopericardium occurred in 6, 3rd degree heart block in 1 patient, sick sinus syndrome in 1 patient and phrenic nerve palsy in 1 patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.It should be noted that additional information received indicated the flexability catheter did not cause or contribute to the perforations, heart block, sick sinus syndrome or phrenic nerve palsy.

Event Description

Additional information indicated the flexability catheter did not cause or contribute to the perforations, heart block, sick sinus syndrome or phrenic nerve palsy.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 3008452825.

• 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16512446
• MDR Text Key: 310966176
• Report Number: 3005334138-2023-00084
• Device Sequence Number: 1
• Product Code: OAD
• 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,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• 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