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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 No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Event Description
During a cryoablation procedure a polarsheath was selected for use.It was reported that a constant leak was observed during the procedure.The polarx balloon catheter was inside the sheath when the leak was identified.No air bubbles were noted.The procedure resumed while the physician proceeded to use compresses to dry the leak.The sheath was not exchanged and the procedure was completed successfully without any patient complications.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection did not note any visible anomaly.Microscopic inspection did note a tear on the valve seal.The sheath passed aspiration testing with syringes at various flow rates and hemostatis valve testing at 5.5 psi.However, the device did not pass aspiration and hemostatis testing while either a dilator a shaft surrogate was inserted into the sheath and tipped at slight angles.The device was gently pressurized with 6 psi at the flushing line luer fitting while plugging the distal tip of the catheter.The valve body was then submerged in a beaker of water.A steady stream of bubbles appeared at the valve region where the tear and valve slits were noted.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
During a cryoablation procedure a polarsheath was selected for use.It was reported that a constant leak was observed during the procedure.The polarx balloon catheter was inside the sheath when the leak was identified.No air bubbles were noted.The procedure resumed while the physician proceeded to use compresses to dry the leak.The sheath was not exchanged and the procedure was completed successfully without any patient complications.
 
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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 Key11059585
MDR Text Key223773871
Report Number2134265-2020-18368
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
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2021
Device Model NumberM004CRBS3050
Device Lot Number0025996550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Date Manufacturer Received02/03/2021
Patient Sequence Number1
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