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

Lot Number 0030560146

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

Patient Problem Nerve Damage (1979)

Event Date 08/27/2023

Event Type  Injury  

Event Description

Clinical study py007 for polar smart; subject id (b)(6).It was reported that during a cryo-ablation procedure using a polarsheath the patient experienced phrenic nerve palsy (pnp).An x-ray was performed.No further information was provided.The procedure and patient outcome are unknown.Additional information was retrieved.A pre-discharge visit with the patient occurred on (b)(6)2023.No existing atrial fibrillation was noted.However, the patient has ongoing phrenic nerve palsy (pnp).The site has not performed a 3 month visit and it is not required.

Manufacturer Narrative

There is no indication 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

There is no indication 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

Clinical study py007 for polar smart; subject id (b)(6).It was reported that during a cryo-ablation procedure using a polarsheath the patient experienced phrenic nerve palsy (pnp).An x-ray was performed.No further information was provided.The procedure and patient outcome are unknown.Additional information was retrieved.A pre-discharge visit with the patient occurred on (b)(6) 2023.No existing atrial fibrillation was noted.However, the patient has ongoing phrenic nerve palsy (pnp).The site has not performed a 3 month visit and it is not required.Further additional information was received.X-ray examination revealed decreased activity of the right diaphragm, but not total immobility.The catheter has been discarded.The event has been determined to be resolved on resolved (b)(6) 2023.

• 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: 17982931
• MDR Text Key: 326233979
• Report Number: 2124215-2023-58042
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Lot Number: 0030560146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 47 KG