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-FJ

Device Problem High impedance (1291)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/14/2021

Event Type  Injury  

Event Description

During a radio frequency ablation procedure, myocardial tissue was noted on the tip of the catheter.During the procedure, a rise in impedance was noted after 20 minutes every time the catheter was placed in a specific location.The catheter appeared to have a strange wiggle on ensite in the same spot.Impedance was normal in every other position and the catheter looked normal.Upon removal from the patient, the catheter had what seemed to be myocardial tissue on the tip of the catheter between the irrigation holes.The tissue was removed, and the decision was made to stop ablating as the physician did not want to cause any further damage.In that specific spot, the catheter was not able to reach the intended power numbers because the irrigation holes were obstructed and the temperature of the tip was too high.The procedure was completed with no consequences to the patient.

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.

Manufacturer Narrative

One quadripolar, bi-directional, curve f-j, flexibility sensor enabled ablation catheter was received for evaluation.Electrode 1 met specifications for acceptable resistance values with no open or short circuits detected.Microscopic inspection of the tip electrode revealed no anomalies.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 tissue on the catheter tip remains unknown.

• 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
• MDR Report Key: 11855850
• MDR Text Key: 251714229
• Report Number: 3005334138-2021-00342
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 7398243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 112