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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 12/07/2020
Event Type  malfunction  
Event Description
During a cryoablation procedure a polarsheath was selected for use.It was reported that the physician heard a hissing noise near the sheath as if air was being sucked in after the third freeze.The sheath was immediately withdrawn into the right atrium and an attempt to aspirate air was made.No air was aspirated or visible inside the sheath and its sideport.No fluid of any kind was observed either.The procedure was completed successfully without exchanging the sheath and no patient complications were reported.
 
Event Description
During a cryoablation procedure a polarsheath was selected for use.It was reported that the physician heard a hissing noise near the sheath as if air was being sucked in after the third freeze.The sheath was immediately withdrawn into the right atrium and an attempt to aspirate air was made.No air was aspirated or visible inside the sheath and its sideport.No fluid of any kind was observed either.The procedure was completed successfully without exchanging the sheath and no patient complications were reported.
 
Manufacturer Narrative
The reported failure was confirmed through analysis.Visual inspection revealed a small tear intersecting the outer slit on the valve seal.It was also observed that the irrigation flush line was crimped.The device passed functional testing including pressure decay, hemostasis at 5.5 psi pressurization, and aspiration with 10 cc and 60 cc syringes at various flowrates.However, the device did not pass aspiration tests while a shaft surrogate was inserted into the sheath, tipped at slight angles and withdrawn.Device was gently pressurized with 6 psi at the flushing line luer fitting while plugging the distal tip of the catheter.The valve body was then submerged in a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.The bubbles appeared to form only at the tear(s) and valve slits.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.
 
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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 Key11123611
MDR Text Key226650707
Report Number2134265-2020-18805
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 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2021
Device Model NumberM004CRBS3050
Device Lot Number0025977549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Date Manufacturer Received02/03/2021
Patient Sequence Number1
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