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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 10/20/2021
Event Type  malfunction  
Event Description
It was reported that a polarsheath was selected for a paroxysmal atrial fibrillation cryoablation ablation procedure. During preparation prior to introduction into the patient, the doctor noticed that when aspirating from the side port, a lot of air was entering despite the tip of the polarsheath being immersed in a basin of water. The physician then decided to flash and aspirate, even trying to keep the valve close, but the problem returned. The sheath was replaced and the procedure was completed successfully. No patient complications were reported. The device is expected to be returned for analysis.
 
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.
 
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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 Key12739062
MDR Text Key281413053
Report Number2134265-2021-13772
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM004CRBS3050
Device Lot Number0027820918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown
Removal/Correction Number92688876-FA

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