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 Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/10/2020

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

(b)(6) clinical study.It was reported that the patent experienced arterial hypotension at the end of an cryoablation procedure involving a polarx balloon and polarsheath.The patient was diagnosed with chest pain, cardiac tamponade and pericardial effusion.Morphine and percutaneous needle drainage were performed.The patient has recovered and case was considered resolved on (b)(6) 2020.The suspected cause was due to a right atrial wound during transeptal puncture.

Event Description

Polar ice clinical study it was reported that the patent experienced arterial hypotension at the end of an cryoablation procedure involving a polarx balloon and polarsheath.The patient was diagnosed with chest pain, cardiac tamponade and pericardial effusion.Morphine and percutaneous needle drainage were performed.The the patient has recovered and case was considered resolved on (b)(6) 2020.The suspected cause was due to a right atrial wound during transeptal puncture.Additional information received indicated that diagnostic testing of echography was also performed.

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence this device was used in a manner inconsistent with the labeled indications additional information was added to event.

• 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: 12857519
• MDR Text Key: 281194243
• Report Number: 2134265-2021-14690
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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: 06/19/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025830926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 36 KG