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

Lot Number 0030807699

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

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980)

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported that during a cryo balloon catheter ablation (cbca) procedure to treat atrial fibrillation a polarx catheter was selected for use.When the right inferior pulmonary vein (ripv) was being ablated the patient's diaphragm movement slowed down.Ablation was immediately ceased, and the balloon was deflated.It was noted that the complication phenic nerve activity may have been discovered late because pacing was not going well.The procedure was completed with no patient complications.However, the patient was held for observation.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 balloon catheter ablation (cbca) procedure to treat atrial fibrillation a polarx catheter was selected for use.When the right inferior pulmonary vein (ripv) was being ablated the patient's diaphragm movement slowed down.Ablation was immediately ceased, and the balloon was deflated.It was noted that the complication phenic nerve activity may have been discovered late because pacing was not going well.The procedure was completed with no patient complications.However, the patient was held for observation.The device is not expected to be returned for analysis due to disposal.

Manufacturer Narrative

Correction to the initial mdr in blocks and h6 patient codes and h6 impact codes.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.

• 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: 17654837
• MDR Text Key: 322330798
• Report Number: 2124215-2023-45314
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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 Expiration Date: 11/18/2023
• Device Lot Number: 0030807699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other