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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 05/11/2022
Event Type  malfunction  
Event Description
It was reported that during preparation for a cryoablation to treat atrial fibrillation air was observed in the polarsheath steerable sheath. Prior to insertion of the dilator or any other devices or tools into the to the sheath, the sheath was flushed with saline and then aspirated from a bowel of saline. After performing the aspiration air was observed in the syringe. The step was performed several times but air was still in the sheath. The customer commented that the air seemed coming from the hemostatic valve. The sheath was replace by another one but the issue occurred again. After the second exchange the new sheath worked fine. The procedure was successfully completed with no patient complications. Device is expected to be returned.
 
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 Key14490662
MDR Text Key296050176
Report Number2134265-2022-05928
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSW
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 07/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/03/2022
Device Model NumberM004CRBS3050
Device Lot Number0028069794
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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