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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 CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number M004CRBSUSC3050
Device Problem Leak/Splash (1354)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2020
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 cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use. It was reported that air was aspirated into the sheath and hemostatic valve during irrigation prior to the start of the procedure. Aspiration was slowed by placing a finger over the hemostatic valve. The sheath was never inserted into the patient so the procedure was resumed after exchanging the sheath. No fluid lead was observed. The procedure was completed with no patient complications.
 
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Brand NamePOLARSHEATH
Type of DeviceCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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 Key10900287
MDR Text Key219328328
Report Number2134265-2020-16396
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2021
Device Model NumberM004CRBSUSC3050
Device Lot Number0025996540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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