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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.
 
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Brand NamePOLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key12392346
MDR Text Key270512227
Report Number2134265-2021-11034
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were 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
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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