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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 Problems Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
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. 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 april 13, 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.
 
Event Description
It was reported that during a procedure involving a polarsheath device the cap on back of the handle detached. When a balloon catheter that was inserted though the polarsheath was removed, the valve of the sheath began to leak. The polarsheath could not be used to continue with rf (radiofrequency) ablation. No patient complications were reported. 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 Key11711980
MDR Text Key249325332
Report Number2134265-2021-05174
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/13/2021
Device Model NumberM004CRBS3050
Device Lot Number0026287706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown
Removal/Correction Number92688876-FA

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