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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 Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Event Date 03/22/2021
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
(b)(6). It was reported that a poalrsheath and polarx were selected for a cryoablation procedure after a sheath exchange the patient developed inferolateral st elevation. It was noted that the patients blood pressure dropped and was "clammy". A echo was performed which excluded tamponade and showed good left ventricular contractility. The st elevation persisted and the decision was made to perform coronary angiography. Coronary angiography showed coronaries were normal and st elevation was settled. It was the clinical impression of an air embolism occurred. Ablation continued with no further complications occurred. The patient stayed over night and was discharged the next day.
 
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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 DE COSTA RICA S.R.L.
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 Key11649200
MDR Text Key244899054
Report Number2134265-2021-04710
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 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM004CRBS3050
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 Received03/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/12/2021 Patient Sequence Number: 1
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