MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRYOABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 07/01/2021

Event Type  Injury  

Event Description

During a cryo ablation procedure, the patient experienced phrenic nerve function loss.After successful transseptal puncture, the catheter was placed with no issues.The catheter was positioned in the right subclavian vein near the phrenic nerve.Pacing at l000ms, 20ma and l0msm palse width was started to assess phrenic nerve function.The phrenic nerve function was good and the pacing catheter was shadowed for location.After the right superior pulmonary vein was cannulated, cryo ablation was started.Pacing of the phrenic nerve was started at 15 seconds and right superior pulmonary vein isolation was achieved at 23 seconds.The physician then stopped cryo ablation at 28 seconds due to loss of phrenic nerve response to pacing.The position of the supreme was checked by fluoroscopy and ensite mapping and confirmed no change.The catheter was repositioned to several points nearby and pacing was initiated with no response.It was decided to wait 30 minutes to determine whether phrenic nerve response would return.Pacing was continued at l000ms, 20ma and l0ms pulse width during the wait time.The physician repeated the pacing techniques for phrenic nerve response with no change.The procedure was stopped due to this event.The patient is currently in stable condition, and is being monitored periodically to assess whether phrenic nerve function will return.No further treatment is planned at this time.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CRYOABLATION SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17526377
• MDR Text Key: 321135314
• Report Number: MW5133316
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1