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 10/06/2020

Event Type  malfunction  

Event Description

It was reported that a polarsheath was used in a pulmonary vein isolation ablation procedure.It was noted that when a catheter was in the sheath the sideport leaked saline.When no catheter was in the sheath no leak occurred from the side port and when the catheter was removed the leak also occurred from the hemostatic valve.The procedure was completed using this device with no patient complications being reported.

Event Description

It was reported that a polarsheath was used in a pulmonary vein isolation ablation procedure.It was noted that when the catheter was inserted into the sheath, the side port leaked saline.When the catheter was removed, leaking from the side port was not observed but there was some leaking from the hemostatic valve.There was no air ingress observed.The procedure was completed using this sheath with no patient complications being reported.The polarsheath was returned for laboratory analysis.

Manufacturer Narrative

Visual inspection of the returned device revealed a tear in the valve seal that intersected the outer slit, and the distal tip of the sheath was deformed.A crimp/kink was noted on the irrigation tubing.The device passed 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.The device did not pass aspiration testing after removing the dilator and polarx test catheter from sheath.The device did not pass hemostasis testing when the polarx test catheter was tipped at an angle while inserted into the sheath.An air pressure test was conducted.The device was gently pressurized with 6 psi at the flushing line luer fitting and the distal tip of the catheter was closed off.The valve body was then submerged in a beaker of water.No air bubbles were noted throughout this test.Laboratory analysis confirmed the a tear in the hemostatic valve led to the leaking observed during the procedure.Analysis also found a crimp/kink in the irrigation tubing that that may have contributed to the saline leaking from the side port when the catheter was inserted into the sheath during the procedure.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: 10778725
• MDR Text Key: 216374680
• Report Number: 2134265-2020-15203
• 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: 12/14/2020

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: 06/03/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025760601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/14/2020
• Patient Sequence Number: 1