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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); Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
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 a polarx and polarsheath were selected for paroxysmal atrial fibrillation ablation procedure.The polarsheath was inserted into the left atrium, as the dilatator was being removed, blood was noted leaking out of the hemostatic valve.The sheath was replaced and the procedure was continued.During the first ablation with the polarx in the left superior pulmonary vein, no temperature drop was noted when ablation was started.Time to isolation (tti) was displayed as an indication ablation was working, ablation was halted.The console was restarted and the cables were exchanged, however the issue was not resolved.The polarx was exchanged and the procedure was completed.No patient complications occurred.The polarsheath and polarx are expected to be returned for analysis.
 
Manufacturer Narrative
The returned device had no visual defects observed during visual inspection.Visual inspection of the valve revealed a possible inner tear.Sheath was able to hold the deflection properly with no issues.Steering was acceptable with no abnormal resistance in the handle.The device failed the aspiration testing as bubbles were observed in flush line during vacuum.The device passed the standard hemostasis valve pressure decay testing.The sheath was set through extensive engineering evaluation related to inserting the dilator into the sheath.The sheath did not pass all extensive testing in aspiration and hemostasis when a dilator was inserted and then removed.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that a polarx and polarsheath were selected for paroxysmal atrial fibrillation ablation procedure.The polarsheath was inserted into the left atrium, as the dilatator was being removed, blood was noted leaking out of the hemostatic valve.The sheath was replaced and the procedure was continued.During the first ablation with the polarx in the left superior pulmonary vein, no temperature drop was noted when ablation was started.Time to isolation (tti) was displayed as an indication ablation was working, ablation was halted.The console was restarted and the cables were exchanged, however the issue was not resolved.The polarx was exchanged and the procedure was completed.No patient complications occurred.The polarsheath and polarx are expected to be returned for analysis.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 Key11546097
MDR Text Key243123834
Report Number2134265-2021-03706
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 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2021
Device Model NumberM004CRBS3050
Device Lot Number0026123738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2021
Date Manufacturer Received05/11/2021
Removal/Correction Number92688876-FA
Patient Sequence Number1
Patient Age59 YR
Patient Weight133
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