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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 Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); ST Segment Elevation (2059); Weakness (2145)
Event Date 09/10/2020
Event Type  Injury  
Event Description
It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure, they had successfully ablated three veins. When they were ablating the last vein (right superior pulmonary vein (rspv)), the physician stopped the ablation due to no effect using a single stop. After the polarx balloon deflated, they observed a small st segment elevation (2mv). The elevation lasted for a minute, and during that minute, after about 30 seconds they got error 1 - 00004000-2: console detected blood in catheter. They immediately pulled out the catheter and found blood inside of the balloon catheter. The blood also got into the cryo gas cable. They exchanged the polarx balloon catheter and the cryo gas cable, and tried again. The exact same problem recurred. This time, the st segment elevation (2mv) lasted for only 30 seconds. They then decided to exchange the polarx balloon catheter, the polarsheath, the polarmap mapping catheter and the cryo gas cable. Afterwards, they were able to ablate the rspv without any further issues and completed the case. The patient was fine when he left the laboratory, without any further events. Six hours after the case, the physician reported that the patient experienced a stroke and that he was being medicated. The patient's status pending. The products are 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 Key10580701
MDR Text Key208378458
Report Number2134265-2020-13274
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/16/2021
Device Model NumberM004CRBS3050
Device Lot Number0025818181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2020 Patient Sequence Number: 1
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