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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 Atrial Flutter (1730); Chest Pain (1776); Dyspnea (1816); Palpitations (2467)
Event Date 12/06/2020
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
Clinical study polar ice py003 it was reported that following a cryoablation the patient developed chest pain, shortness of breath (sob) and palpitations overnight. The next day, his wife called an ambulance and the patient was taken to the local hospital. He was admitted and an electrocardiogram (ecg) diagnosed atrial flutter. Bloodwork and chest x-ray was performed; the results were not reported. The patient's oral bisoprolol was increased from 2. 5mg to 5mg and the symptoms settled by that evening. The patient was then discharged. The device is not 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 Key11206824
MDR Text Key227918355
Report Number2134265-2021-00540
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/17/2021
Device Model NumberM004CRBS3050
Device Lot Number0025676920
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/21/2021 Patient Sequence Number: 1
Treatment
POLARX
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