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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Event Description
It was reported that during a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use. It was reported that air bubbles were observed in the syringe when fluid was being sucked up. The polarsheath was exchanged and the procedure was completed successfully with no patient complications. This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
 
Manufacturer Narrative
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device. On (b)(6) 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.
 
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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 Key12751603
MDR Text Key281429669
Report Number2134265-2021-13878
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/20/2021
Device Model NumberM004CRBS3050
Device Lot Number0026767452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction Number92688876-FA

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