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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

During a pulmonary vein isolation cryoablation procedure, a polarsheath was selected for use.It was reported that blood was leaking from the hemostatic valve after the polarx balloon catheter was inserted inside the sheath.No air was observed.The sheath was exchange and the procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Initial visual and microscope inspections of the valve showed a tear.The device passed pressure decay testing at 6 psi, hemostasis at 5.5 psi pressurization with saline, and aspiration with 10 cc and 60 cc syringe at various flowrates.The device did not pass both hemostasis and aspiration testing while the polarx test catheter or dilator were inserted and removed.Air pressure testing was performed to identify the location of any potential leaks.The device was gently pressurized at the flushing line luer fitting while plugging the distal tip of the catheter; the measurements were within the acceptable range and no air bubbles were observed.Laboratory analysis confirmed that a tear in the hemostatic valve most likely led to the blood leaking observed during the procedure.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.

Event Description

During a pulmonary vein isolation cryoablation procedure, a polarsheath was selected for use.It was reported that blood was leaking from the hemostatic valve after the polarx balloon catheter was inserted inside the sheath.No air was observed.The sheath was exchange and the procedure was completed successfully.No patient complications were reported.

• 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: 10756210
• MDR Text Key: 215279977
• Report Number: 2134265-2020-14993
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025676920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/18/2020
• Patient Sequence Number: 1