MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, 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 Key: 10726841
• MDR Text Key: 212733570
• Report Number: 2134265-2020-14693
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/22/2021
• Device Model Number: M004CRBSUSC3050
• Device Lot Number: 0025586327
• 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 Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• 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