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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 Fibrillation (1729); Fever (1858); Hemoptysis (1887); Pneumonia (2011)
Event Date 11/28/2020
Event Type  Injury  
Manufacturer Narrative
Weight: (b)(6). 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 (b)(6). It was reported that day following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient felt unwell, went to the local emergency department and was hospitalized. An electrocardiogram (ecg) showed atrial fibrillation (af). He was noted to also have hemoptysis and a fever. The patient was given amiodarone and went back into sinus rhythm (sr) the next day. Two days later, the patient went back into af but reverted back to sr on the same day. A diagnosis of right sided community acquired pneumonia and infection driven atrial fibrillation recurrence was made. The patient was discharged two days later. The event outcome was reported as ongoing. The devices are 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 Key11132776
MDR Text Key225574085
Report Number2134265-2020-18848
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 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/23/2021
Device Model NumberM004CRBS3050
Device Lot Number0025850016
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 Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
Treatment
POLARX
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