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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
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.
 
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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
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key11012756
MDR Text Key221726914
Report Number2134265-2020-17811
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
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/19/2021
Device Model NumberM004CRBS3050
Device Lot Number0025977551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2020
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
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