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 Air Embolism (1697); ST Segment Elevation (2059)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: event date was not reported and is estimated.

Event Description

(b)(6) clinical study.It was reported that a cryoablation procedure to treat paroxysmal atrial fibrillation (af) was completed with a polarx balloon catheter and a polarsheath.All of the disposables were prepped according to the directions for use (dfu), and no air bubbles were observed during the preparation phase.There were no issues whatsoever noticed during the procedure.At the end of the procedure, while observing 12 lead electrocardiogram (ecg), there were st elevations seen in all the leads, which indicated air embolism, either through the polarsheath or the polarx balloon catheter irrigation system.The catheter had been removed and reinserted into the patient only once and the irrigation was not interrupted or stopped during the procedure.The physician commented that it was likely that the incident was caused by the polarsheath.The medical interventions taken were unknown; however, the patient fully recovered.The device has been returned to the manufacturer and is pending analysis.

Manufacturer Narrative

Date of event: corrected to (b)(6) 2020.

Event Description

Polar ice clinical study: it was reported that a cryoablation procedure to treat paroxysmal atrial fibrillation (af) was completed with a polarx balloon catheter and a polarsheath.All of the disposables were prepped according to the directions for use (dfu), and no air bubbles were observed during the preparation phase.There were no issues whatsoever noticed during the procedure.At the end of the procedure, while observing 12 lead electrocardiogram (ecg), there were st elevations seen in all the leads, which indicated air embolism, either through the polarsheath or the polarx balloon catheter irrigation system.The catheter had been removed and reinserted into the patient only once and the irrigation was not interrupted or stopped during the procedure.The physician commented that it was likely that the incident was caused by the polarsheath.The medical interventions taken were unknown; however, the patient fully recovered.The device has been returned to the manufacturer and is pending analysis.

Event Description

Polar ice clinical study: it was reported that a cryoablation procedure to treat paroxysmal atrial fibrillation (af) was completed with a polarx balloon catheter and a polarsheath.All of the disposables were prepped according to the instructions for use (ifu), and no air bubbles were observed during the preparation phase.There were no issues whatsoever noticed during the procedure.At the end of the procedure, while observing 12 lead electrocardiogram (ecg), an st elevation was observed on all the leadspresuming anair embolism occurred either through the polarsheath or the polarx balloon catheter irrigation system.The catheter had been removed and reinserted into the patient only once and the irrigation was not interrupted or stopped during the procedure.The physician commented that it was likely the incident was caused by the polarsheath.The medical interventions taken were unknown; however, the patient fully recovered.The device was returned for laboratory analysis.

Manufacturer Narrative

Visual inspection of the returned device revealed saline on the handle, and a tear in the inner section of the valve.Functional testing was performed.The device passed the pressure decay testing at 6 psi, hemostasis testing at 5.5 psi pressurization with saline, and aspiration testing with 10 cc and 60 cc syringe at various flowrates.Additional aspiration and hemostasis testing was conducted with a polarx catheter inserted in the polarsheath to further evaluate the hemostatic valve limits under induced manipulation.No air bubbles and leaking were observed when the polarx test catheter was inserted into the sheath and tipped at various angles; no air bubbles/leaking noted once the catheter was removed, indicating the hemostatic valve maintained appropriate integrity.Laboratory analysis found no evidence that the polarsheath may have contributed to the clinical observations.Although there was a tear in the inner section of the hemostatic valve, the sheath did not leak or allow air ingress throughout testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.There is no evidence this device was used in a manner inconsistent with the labeled indications.The polarsheath instructions for use (ifu) contains warnings, precautions and instructions for the user to minimize the risk of air embolism.Boston scientific engineers and medical safety team reviewed this event and concluded that the event is anticipated in nature as per the ifu.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 10619444
• MDR Text Key: 209570891
• Report Number: 2134265-2020-13644
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025780027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 11/23/2020
• Patient Sequence Number: 1
• Treatment: POLARX BALLOON CATHETER; POLARX BALLOON CATHETER; POLARX BALLOON CATHETER; POLARX BALLOON CATHETER
• Patient Outcome(s): Other