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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 Low Blood Pressure/ Hypotension (1914); Heart Block (4444)
Event Date 06/28/2021
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
It was reported that during a paroxysmal atrial fibrillation cryoablation procedure involving a polarx catheter, polarsheath, and polarmap. The patient became hypotensive (50mmhg systolic) when ablating the right sided veins, the left side veins had been fine. There was a brief period of 2:1 av block during this time. No effusion was seen on echo and fluid and medication was given to improve the patient's blood pressure. The patient recovered and the procedure was completed. All freezes were around -65 degrees with none being -70 degrees. Patient left the lab in sr. In recovery the patient became unwell and very hypotensive and went in complete av block, because very unwell, the patient was re-scanned again and no effusion seen. The patient was taken to the lab for an insertion of a pacemaker and then went to itu. There was no st segment changes during or post procedure that the team noted.
 
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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 Key12198245
MDR Text Key262607779
Report Number2134265-2021-09300
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/23/2021
Device Model NumberM004CRBS3050
Device Lot Number0026794462
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 Received06/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1
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