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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non specific EKG/ECG Changes (1817); ST Segment Elevation (2059)

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure to treat paroxysmal atrial fibrillation, the polarsheath was prepared and used following the new sheath management guidelines, continuously flushed with a pressure bag. The dilator was wiped with saline prior to introduction into the valve. The polarsheath dilator and polarx balloon were placed across the valve. They ablated the left veins without issues. When they ablated the right superior pulmonary vein (rspv), they noted an st segment elevation and stopped the ablation. They tried aspiration from the sheath while the polarx balloon was in left atrium (la). They were able to aspirate a lot of air. They then took out the polarx and aspirated it again - no air was aspirated that time. They waited for the st segment elevation to resolve and then again introduced the balloon inside the polarsheath and aspirated with balloon in la. Again, they were able to aspirate air. It was decided to replace the polarsheath. After the polarsheath was replaced, the procedure was completed successfully. The st segment elevation resolved prior to any additional ablations. The polarx was in place when the leak occurred. They only saw the st segment elevation, without fluid coming from the sheath's valve. After taking out the catheter, they could aspirate a lot of air. No fluid was seen out of the sheath. The air was going inside the hemostatic valve. The patient was fine after the procedure. The devices are expected to be returned for analysis.

• Brand Name: POLARSHEATH
• 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: 11012756
• MDR Text Key: 221726914
• Report Number: 2134265-2020-17811
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/19/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025977551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/15/2020 Patient Sequence Number: 1