MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARX; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Lot Number 0032675795

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

Patient Problems Dyspnea (1816); Nerve Damage (1979)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a cryo pulmonary vein isolation (pvi) procedure to treat atrial fibrillation a polarx catheter was selected for use.The first freeze of the right superior pulmonary vein (rspv) was stopped due to warm temperatures.The second freeze was double stopped when phrenic nerve activity started to gradually decrease.Phrenic nerve activity was monitored via pacing from the orion mapping catheter in the superior vena cave (svc).Pacing of the phrenic nerve tried periodically for the next hour, but no stimulation was ever recovered.The left superior pulmonary vein (lspv) had been ablated and a radiofrequency ablation device was used to isolate the right inferior pulmonary vein (ripv).The procedure was competed with no patient complications.The device is not expected to be returned for analysis due to disposal.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a cryo pulmonary vein isolation (pvi) procedure to treat atrial fibrillation a polarx catheter was selected for use.The first freeze of the right superior pulmonary vein (rspv) was stopped due to warm temperatures.The second freeze was double stopped when phrenic nerve activity started to gradually decrease.Phrenic nerve activity was monitored via pacing from the orion mapping catheter in the superior vena cave (svc).Pacing of the phrenic nerve tried periodically for the next hour, but no stimulation was ever recovered.The left superior pulmonary vein (lspv) had been ablated and a radiofrequency ablation device was used to isolate the right inferior pulmonary vein (ripv).The procedure was competed with no further patient complications.The device is not expected to be returned for analysis due to disposal.It was further reported that the patient was kept at the hospital over the weekend after the procedure.The patient was clearly out of breath due to the complication.

• Brand Name: POLARX
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18274908
• MDR Text Key: 329839304
• Report Number: 2124215-2023-68918
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0032675795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other