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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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
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
During a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that bubbles and air was visible in the "irrigation cable" when polarx balloon catheter insertion into the sheath was attempted during preparation.Insertion was attempted two more times prior to sheath exchange.After the exchange the procedure resumed successfully with no patient complications.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection did not reveal any damages, however, a non-optimal slit location displayed a tear on the outer slit.Standard and extensive testing via aspiration and hemostatis valve did not confirm the observation of bubbles in the flush line.The device passed all testing relative to the reported observation.The device was tested for leaks and no bubbles were observed.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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
During a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that bubbles and air was visible in the "irrigation cable" when polarx balloon catheter insertion into the sheath was attempted during preparation.Insertion was attempted two more times prior to sheath exchange.After the exchange the procedure resumed successfully with no patient complications.Additional information received indicated that the dilator was wiped with saline prior to introduction into the valve.When the physician attempted to insert the balloon into the sheath, air appeared in flushing port of the sheath.We thought that air was entering into the sheath when he inserted the balloon.The physician tried to re-insert the polarx to remove the air observed, but air observed again.Therefore, the sheath was exchanged.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
 
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Brand Name
POLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS 
MDR Report Key12017749
MDR Text Key260019968
Report Number2134265-2021-07802
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Notification
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/13/2021
Device Model NumberM004CRBS3050
Device Lot Number0026733389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Date Manufacturer Received06/18/2021
Removal/Correction Number92688876-FA
Patient Sequence Number1
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