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 Problem Headache (1880)

Event Date 03/02/2021

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 polarx cryoablation procedure involving a polarsheath, the patient presented to the emergency room (er) with a headache.The suspected cause was unknown.The patient was given intravenous (iv) morphine for the headache.The device is not expected to be returned for analysis.

Event Description

Clinical study frozen (b)(6).It was reported that following a polarx cryoablation procedure involving a polarsheath, the patient presented to the emergency room (er) with a headache.The suspected cause was unknown.The patient was given intravenous (iv) morphine for the headache.The device is not expected to be returned for analysis.It was further reported that the patient had a headache ever since he came out of his index procedure.The headache subsided and patient was sent home he next day.Since being discharged, the patient has had bad headaches that eventually led him to going to the er for help.

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.

• 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
• MDR Report Key: 11604340
• MDR Text Key: 243529342
• Report Number: 2134265-2021-04237
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: M004CRBSUSC3050
• Device Lot Number: 0025971563
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/06/2021
• Patient Sequence Number: 1
• Treatment: POLARX.; POLARX.; POLARX
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 95