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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 Difficult to Flush (1251)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Event Description
It was reported that irrigation difficulties occurred.The polarsheath was used in a de novo pulmonary vein isolation procedure.The polarsheath was prepared according to the instructions for use (ifu).It was noted that the transseptal access was slightly hard to make, but sheath glided to left "nicely".Irrigation was performed using a non-boston scientific irrigation pump with about 120ml/h.Another physician did a water bridge on the tip of the polarx balloon catheter and flow to the sheath was increased to 1100ml/h or 1200ml/h.Almost immediately during catheter insertion into the sheath the pump gave a resistance / pressure alarm.The 3-way stop cock was tested and was flushing properly from the side port.The non-boston scientific pump unit was changed but the issue persisted.A new polarsheath was prepared for use with the same polarx balloon.Once again when putting the polarx catheter into sheath, the same error occurred.The polarx balloon was removed from the sheath, sheath aspiration was performed and no bubbles were seen.The polarsheath and polarx balloon were removed form the patient and tested using manual irrigation, he commented that there was some resistance, but not really much.The procedure was completed successfully with a new polarsheath and polarx catheter, no patient complications were reported.Following the procedure the secondary physician commented that they perhaps they had pushed the balloon shield a bit too tightly to valve.
 
Event Description
It was reported that irrigation difficulties occurred.The polarsheath was used in a de novo pulmonary vein isolation procedure.The polarsheath was prepared according to the instructions for use (ifu).It was noted that the transseptal access was slightly hard to make, but sheath glided to left "nicely".Irrigation was performed using a non-boston scientific irrigation pump with about 120ml/h.Another physician did a water bridge on the tip of the polarx balloon catheter and flow to the sheath was increased to 1100ml/h or 1200ml/h.Almost immediately during catheter insertion into the sheath the pump gave a resistance / pressure alarm.The 3-way stop cock was tested and was flushing properly from the side port.The non-boston scientific pump unit was changed but the issue persisted.A new polarsheath was prepared for use with the same polarx balloon.Once again when putting the polarx catheter into sheath, the same error occurred.The polarx balloon was removed from the sheath, sheath aspiration was performed and no bubbles were seen.The polarsheath and polarx balloon were removed form the patient and tested using manual irrigation, he commented that there was some resistance, but not really much.The procedure was completed successfully with a new polarsheath and polarx catheter, no patient complications were reported.Following the procedure the secondary physician commented that they perhaps they had pushed the balloon shield a bit too tightly to valve.
 
Manufacturer Narrative
Visual inspection of the device showed no major abnormalities found.Inserting a polarx through the sheath revealed no issues related to valve housing or insertion.Using a metriq pump to irrigate the returned device revelated during actively pumping without any error messages or issues with the output of the liquid from sheath.Pin gage measurements of inner diameter (id) of distal tip and valve housing showed no protrusions from any material to restrict insertion.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 Key12392346
MDR Text Key270512227
Report Number2134265-2021-11034
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 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/03/2021
Device Model NumberM004CRBS3050
Device Lot Number0026681222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Date Manufacturer Received10/07/2021
Patient Sequence Number1
Treatment
POLARMAP; POLARMAP; POLARX BALLOON CATHETER; POLARX BALLOON CATHETER
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