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

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

Patient Problems Nerve Damage (1979); Neuropathy (1983)

Event Date 12/09/2023

Event Type  Injury  

Event Description

It was reported that after an ablation procedure to treat atrial fibrillation using a polarxfit catheter the patient experienced esophageal neuropathy and could not eat from the mouth.It was believed that the ablation treatment performed in the left inferior pulmonary vein (lipv) may have caused damage to the esophageal nerve.The patient was placed on 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.

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 after an ablation procedure to treat atrial fibrillation using a polarxfit catheter the patient experienced esophageal neuropathy and could not eat from the mouth.It was believed that the ablation treatment performed in the left inferior pulmonary vein (lipv) may have caused damage to the esophageal nerve.The patient was placed on observation the device is not expected to be returned for analysis due to disposal.It was further reported that the patient was discharged from the hospital but was still under observation afterwards.

• Brand Name: POLARXFIT
• 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: 18367543
• MDR Text Key: 331020080
• Report Number: 2124215-2023-70874
• 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: 01/11/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/24/2023
• Supplement Dates FDA Received: 01/11/2024
• 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
• Patient Outcome(s): Hospitalization