MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP

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

Patient Problems Nerve Damage (1979); Cardiac Tamponade (2226)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported via a seminar, that during cryoablation procedure performed at a single center from (b)(6) 2021 to (b)(6) 2022, involving polarx balloon catheters, polarmap catheters, and polarsheath steerable sheaths.Twenty-seven cases of phrenic nerve palsy, one case of cardiac tamponade, and one case of puncture site vascular injury were observed.Of the 27 cases of phrenic nerve palsy, nineteen cases occurred during cooling of the right superior pulmonary vein (rspv), and eight cases occurred during cooling of the right inferior pulmonary vein (ripv).Additionally, twenty patients recovered within one month.No additional information was provided.

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.

• Brand Name: POLARMAP
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 15996260
• MDR Text Key: 305611803
• Report Number: 2124215-2022-53141
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2022

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: 11/25/2022
• Initial Date FDA Received: 12/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: POLARSHEATH/CRYOABLATION
• Patient Outcome(s): Other