• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOLARSHEATH
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 Key10619444
MDR Text Key209570891
Report Number2134265-2020-13644
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
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 Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/08/2021
Device Model NumberM004CRBS3050
Device Lot Number0025780027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2020
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
-
-