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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 11/10/2020
Event Type  Injury  
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.
 
Event Description
(b)(6) clinical study. It was reported that the patent experienced arterial hypotension at the end of an cryoablation procedure involving a polarx balloon and polarsheath. The patient was diagnosed with chest pain, cardiac tamponade and pericardial effusion. Morphine and percutaneous needle drainage were performed. The patient has recovered and case was considered resolved on (b)(6) 2020. The suspected cause was due to a right atrial wound during transeptal puncture.
 
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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 degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key12857519
MDR Text Key281194243
Report Number2134265-2021-14690
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/19/2021
Device Model NumberM004CRBS3050
Device Lot Number0025830926
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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