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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
It was reported that a polarsheath was used in a atrial fibrillation cryoablation procedure. After inserting the catheter into the patient the physician tried to asperate through the side port, but the air was pulled out. The sheath was exchanged and the procedure was completed with no patient injury.
 
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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 Key13068564
MDR Text Key285342478
Report Number2134265-2021-16154
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/27/2022
Device Model NumberM004CRBS3050
Device Lot Number0027506192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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