MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Model Number M004CRBS3050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Heart Block (4444)

Event Date 06/28/2021

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

It was reported that during a paroxysmal atrial fibrillation cryoablation procedure involving a polarx catheter, polarsheath, and polarmap. The patient became hypotensive (50mmhg systolic) when ablating the right sided veins, the left side veins had been fine. There was a brief period of 2:1 av block during this time. No effusion was seen on echo and fluid and medication was given to improve the patient's blood pressure. The patient recovered and the procedure was completed. All freezes were around -65 degrees with none being -70 degrees. Patient left the lab in sr. In recovery the patient became unwell and very hypotensive and went in complete av block, because very unwell, the patient was re-scanned again and no effusion seen. The patient was taken to the lab for an insertion of a pacemaker and then went to itu. There was no st segment changes during or post procedure that the team noted.

• Brand Name: POLARSHEATH
• 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: 12198245
• MDR Text Key: 262607779
• Report Number: 2134265-2021-09300
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/23/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026794462
• 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: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 07/20/2021 Patient Sequence Number: 1