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

Model Number M004CRBS3050

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

Patient Problems Air Embolism (1697); ST Segment Elevation (2059)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: event date was not reported and is estimated.

Event Description

(b)(6) clinical study. It was reported that a cryoablation procedure to treat paroxysmal atrial fibrillation (af) was completed with a polarx balloon catheter and a polarsheath. All of the disposables were prepped according to the directions for use (dfu), and no air bubbles were observed during the preparation phase. There were no issues whatsoever noticed during the procedure. At the end of the procedure, while observing 12 lead electrocardiogram (ecg), there were st elevations seen in all the leads, which indicated air embolism, either through the polarsheath or the polarx balloon catheter irrigation system. The catheter had been removed and reinserted into the patient only once and the irrigation was not interrupted or stopped during the procedure. The physician commented that it was likely that the incident was caused by the polarsheath. The medical interventions taken were unknown; however, the patient fully recovered. The device has been returned to the manufacturer and is pending 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 degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10619444
• MDR Text Key: 209570891
• Report Number: 2134265-2020-13644
• 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,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/08/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025780027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/02/2020 Patient Sequence Number: 1

Treatment

POLARX BALLOON CATHETER