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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

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 about 20 minutes into a pulmonary vein isolation (pvi) ablation procedure, after the transeptal puncture, the polarsheath aspirated air.No patient complications occurred.The device is expected to be returned for analysis.The dilator was wiped with saline prior to introduction into the valve and only the dilator was placed across the valve.No tools were in place when the leak occurred.The case was completed with a new polarsheath.The device is expected to be returned for analysis.

Event Description

It was reported that about 20 minutes into a pulmonary vein isolation (pvi) ablation procedure, after the transeptal puncture, the polarsheath aspirated air.No patient complications occurred.The device is expected to be returned for analysis.The dilator was wiped with saline prior to introduction into the valve and only the dilator was placed across the valve.No tools were in place when the leak occurred.The case was completed with a new polarsheath.The device is expected to be returned for analysis.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual and microscope inspections showed the hemostatic valve region was clean and generally free of residues.The valve body was relatively clean.There were signs of tearing visible in the outer valve surface.After rinsing and gently swabbing exterior of the valve body, there were still signs of tearing visible in outer valve surface.The device passed the aspiration test method as currently released.There were no signs of bubbles in the flushing line during syringe vacuum pulls were observed.The device passed the hemostasis valve test method (using an inserted dilator) as currently released.There were no significant beads of saline observed at the valve body when pressurized to 5.5 psi with saline.The device passed the hemostasis valve test method (using a polarx inserted, instead of dilator) as well.There were no significant beads of saline observed at the valve body when pressurized to 5.5 psi with saline.However, when the polarx was tipped at slight angles (relative to the sheath), the valve developed a slight leak.Note: additional testing, including variations of these tests, as well as imaging and dimensional measurements of the valve, will be completed and further documented.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 10430660
• MDR Text Key: 204282780
• Report Number: 2134265-2020-11408
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025575586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 11/19/2020
• Patient Sequence Number: 1