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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 Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2020
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 pulmonary vein isolation cryoablation procedure, a polarsheath was selected for use.It was reported that air was observed during aspiration after the polarx balloon catheter was were inserted into the patient with the sheath.Air was removed with a syringe and the sheath was removed from inside the patient.The procedure was completed successfully and no patient complications were reported.
 
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 pulmonary vein isolation cryoablation procedure, a polarsheath was selected for use.It was reported that air was observed during aspiration after the polarx balloon catheter was were inserted into the patient with the sheath.Air was removed with a syringe and the sheath was removed from inside the patient.The procedure was completed successfully and no patient complications were reported.Additional information received on 10/30/2020 indicated that blood was observed to be leaking from the hemostatic valve.The sheath was exchanged after removal from the patient then procedure was resumed.
 
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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 Key10755434
MDR Text Key215276982
Report Number2134265-2020-14989
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 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/03/2021
Device Model NumberM004CRBS3050
Device Lot Number0025760601
Was Device Available for Evaluation? No
Date Manufacturer Received10/30/2020
Patient Sequence Number1
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