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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 Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Event Description
It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure with a polarsheath, they were aspirating a lot of air during the aspiration of the sheath.There was no leak during flushing or because of the saline drip.The first step they took was to bring the sheath with dilator inside over the guidewire in the left atrium, then pull out dilator and guidewire.Next, they put the polarx balloon catheter into the sheath, and then used the polarmap as guide to advance the left superior pulmonary vein (lspv).They placed the polarmap into the lspv, and pulled back only the polarsheath with the catheter inside into the right atrium.They then brought out the balloon in the right atrium.After that, they aspirated the sheath manually with a 10cc syringe and aspirated air.After that, the physician flushed the sheath in the right atrium and advanced it into the left atrium to start the procedure.At no time did the patient experience a st-elevation or anything else.The patient had no complications.The device is expected to be returned for analysis.
 
Manufacturer Narrative
B1 adverse event/product problem and b2 outcomes attrib to adv event: corrected to product problem with no outcome.The device was returned to boston scientific for analysis.Upon initial condition visual, it was unable to decipher if tear intersecting outer slit on valve seal (pre-clean).There was a small tear intersecting outer slit on valve seal (post-clean).Visual inspection showed no defects.Aspiration testing showed the device passed the test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the 10 cc syringe with slow draw (approx.1 cc per second) test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the 10 cc syringe with medium draw (approx.2 cc per second) test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the 10 cc syringe with fast draw (approx.5 cc per second) test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the 60 cc syringe with slow draw (approx.6 cc per second) test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the 60 cc syringe with medium draw (approx.12 cc per second) test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the 60 cc syringe with fast draw (approx.30 cc per second) test method as currently released.No signs of bubbles in the flushing line during test/syringe vacuum.The device passed the aspiration test when the polarx surrogate was inserted, failed when tipped at slight angles (relative to the sheath) and passed when it was withdrawn.The device did not pass the aspiration test after the polarx surrogate was removed.The device failed the aspiration test after the dilator was removed after inserting through sheath.Hemostasis valve testing showed the device passed the test method as currently released with the exception of no dilator inserted during the test.No leakage, dripping or pressure drop observed.The device passed when the polarx surrogate was inserted, passed when tipped at slight angles (relative to the sheath) and passed when it was withdrawn.The device passed after the polarx surrogate was removed from the sheath.The device passed when the dilator was inserted.The device passed when the dilator was removed.Air pressure test for location of leaks was performed.The device was gently pressurized with 6 psi at the flushing line luer fitting while plugging the distal tip of the catheter, using an isacc tester.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.The result was pass at 0.0225, 0.0095, 0.0061 psi.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure with a polarsheath, they were aspirating a lot of air during the aspiration of the sheath.There was no leak during flushing or because of the saline drip.The first step they took was to bring the sheath with dilator inside over the guidewire in the left atrium, then pull out dilator and guidewire.Next, they put the polarx balloon catheter into the sheath, and then used the polarmap as guide to advance the left superior pulmonary vein (lspv).They placed the polarmap into the lspv, and pulled back only the polarsheath with the catheter inside into the right atrium.They then brought out the balloon in the right atrium.After that, they aspirated the sheath manually with a 10cc syringe and aspirated air.After that, the physician flushed the sheath in the right atrium and advanced it into the left atrium to start the procedure.At no time did the patient experience a st-elevation or anything else.The patient had no complications.The device is expected to be returned for analysis.
 
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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 Key11149288
MDR Text Key227542236
Report Number2134265-2020-18883
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/07/2021
Device Model NumberM004CRBS3050
Device Lot Number0025535398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Date Manufacturer Received02/02/2021
Patient Sequence Number1
Treatment
POLARMAP; POLARMAP; POLARX; POLARX
Patient Outcome(s) Required Intervention;
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