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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that a polarx balloon catheter, polarsheath, and cryo-gas cable were used in a cryoablation procedure.Upon introducing the polarx through the polarsheath a air bubble was detected/suspected due to st segment elevation.The physician waited until the st segment settled and then continued with the procedure.During the first ablation, while ablating, the physician received error 2 - 00000008-1.The cryo cable was disconnected and ablation was attempted again, however, the.Error message reoccurred.The cryo-gas cable was replaced.With the third attempt, just after replacing the cryo-gas cable, the error message error 2 - 00001000-1 occurred.The catheter was replaced and the procedure was completed with no further patient complications.This product is part of the (b)(4) advisory population for the polarsheath steerable sheath.

• 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: 12059406
• MDR Text Key: 261217234
• Report Number: 2134265-2021-08097
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026287706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other