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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 11/10/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that during preparation of a denovo pulmonary vein isolation cryoablation procedure, a polarsheath was selected for use. The tip of the sheath was immersed in a bowl, and air bubbles were observed in the 20mm syringe during aspiration step of the preparation. The syringe connection between the 3-way stopcock and the sheath were checked. The dilator had not been inserted into the sheath yet. No additional information was provided. This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
 
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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 Key12862446
MDR Text Key282346019
Report Number2134265-2021-14750
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFI
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 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/15/2022
Device Model NumberM004CRBS3050
Device Lot Number0027771415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction Number92688876-FA

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