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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Nausea (1970); Constipation (3274)
Event Date 09/19/2020
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
Clinical study (b)(6). It was reported that following a cryoablation procedure with a polarsheath steerable sheath and polarx cryoablation catheter, the patient experienced constipation and presented to the emergency room (er) complaining of abdominal pain and nausea, no bowel movement since the ablation procedure. The patient was given oral golytely, intravenous fluids and intravenous ondansetron 4mg and the event resolved. The device is not expected to be returned. No further information was provided.
 
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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 Key10726841
MDR Text Key212733570
Report Number2134265-2020-14693
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 health professional,study
Reporter Occupation
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/22/2021
Device Model NumberM004CRBSUSC3050
Device Lot Number0025586327
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/23/2020 Patient Sequence Number: 1
Treatment
POLARX CRYOABLATION CATHETER
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