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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 CATHETER, STEERABLE

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH CATHETER, STEERABLE Back to Search Results
Model Number M004CRBS3050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Speech Disorder (4415)
Event Date 12/17/2020
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 (b)(6). It was reported that following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient experienced a transient ischemic attack (tia). They had dizziness, nausea, vomiting, double vision, and slurred speech. The suspected cause was recurrent atrial fibrillation. No corrective actions were taken and the event resolved two days later. The products are not expected to be returned for analysis.
 
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Brand NamePOLARSHEATH
Type of DeviceCATHETER, STEERABLE
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 Key11231126
MDR Text Key228712664
Report Number2134265-2021-00802
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 Foreign,Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/19/2021
Device Model NumberM004CRBS3050
Device Lot Number0025977551
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
Treatment
POLARX
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