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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 03/17/2021
Event Type  malfunction  
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.
 
Event Description
During a cryoablation procedure a polarsheath was selected for use.It was reported hat irrigation of the sheath stopped when the sheath was pushed towards the balloon.The inability to flush was only observed on the irrigation set, however, it occurred with and without freezing.Irrigation was possible again when the sheath was pulled backwards.No patient complications were reported.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection did not find any physical abnormalities.A polarx balloon catheter within allowable tolerance was used for testing.There were no issues observed while inserting catheter through sheath.Pump was active at 30 ml/min for all flow testing to ensure maximum amount of flow was eligible for implementation.The catheter was placed in the distal tip, middle and valve housing regions of the sheath shaft while flow was active.The irrigation passed without any emerging issues.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
During a cryoablation procedure a polarsheath was selected for use.It was reported hat irrigation of the sheath stopped when the sheath was pushed towards the balloon.The inability to flush was only observed on the irrigation set, however, it occurred with and without freezing.Irrigation was possible again when the sheath was pulled backwards.No patient complications were reported.
 
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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 Key11596256
MDR Text Key244386406
Report Number2134265-2021-04157
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 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2021
Device Model NumberM004CRBS3050
Device Lot Number0026199872
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Date Manufacturer Received06/04/2021
Patient Sequence Number1
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