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

Lot Number 0032537790

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

Patient Problem Nerve Damage (1979)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation using a polarx catheter the patient experienced phrenic nerve palsy.Both left pulmonary veins were ablated without difficulty.During ablation of the right superior pulmonary vein (rspv) phrenic nerve capture was lost after 30-40 seconds.Phenic nerve capture was being monitored by a lab tech keeping a hand on the abdomen of the patient.Ablation was ceased immediately using the stop function on the cryo console.The balloon was not immediately deflated afterwards, but warming was rapid and the balloon deflated in the normal fashion.After 30 minutes of waiting the phrenic nerve palsy had not resolved, so the procedure was cancelled.Plans were made to perform a sniff test later to assess if the phrenic nerve palsy had resolved.The device is expected to be returned for analysis.

• 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: 18250722
• MDR Text Key: 329517919
• Report Number: 2124215-2023-67837
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0032537790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: White