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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 Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2020
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 after a polarsheath was introduced into the patient for a cryo ablation, there was a severe leak from the hemostatic valve.It was noted that the dilator was not flushed on outside surface before being introduced.The procedure was completed with another polarsheath successfully.No patient complications occurred.The device is expected to be returned for analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual and microscope inspections showed the flushing line was filled with blood residues.There was also blood residues surrounding the blue proximal cap and valve body.After rinsing and gently swabbing the exterior of the valve body, there was a noticeable tear extending vertically.Functional testing showed the device passed the test method as currently released.There were no signs of bubbles in the flushing line during syringe vacuum pulls.The device passed the hemostasis valve test method (using an inserted dilator) as currently released.No significant beads of saline were observed at the valve body when pressurized to 5.5 psi with saline.The device passed the hemostasis valve test method (using a polarx inserted, instead of dilator) as well.No significant beads of saline were observed at the valve body when pressurized to 5.5 psi with saline.However, when the polarx was tipped at slight angles (relative to the sheath), the valve developed a noticeable leak.Note, the valve was potentially damaged further by accidental partial insertion of balloon protective sleeve during initial attempts to insert polarx catheter.The protective sleeve was accidentally bumped distally when the polarx balloon passed through the valve housing.Note: additional testing, including variations of these tests, as well as imaging and dimensional measurements of the valve, will be completed and further documented.Dissection of the handle halves showed the interior of handle halves had no signs of blood residues in valve region.There was blood residues surrounding and inside the valve body.After all functional testing was completed, the valve body had a noticeable tear that was appreciably different than as-received condition.Additional tearing likely occurred from insertions of dilator, polarx, and accidental insertion of balloon protective sleeve.Air pressure test to identify the location of leaks was performed.The device was gently pressurized with 2 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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that after a polarsheath was introduced into the patient for a cryo ablation, there was a severe leak from the hemostatic valve.It was noted that the dilator was not flushed on outside surface before being introduced.The procedure was completed with another polarsheath successfully.No patient complications occurred.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 Key10296092
MDR Text Key200398542
Report Number2134265-2020-09565
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/22/2021
Device Model NumberM004CRBS3050
Device Lot Number0025575587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Date Manufacturer Received11/17/2020
Patient Sequence Number1
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