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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported that a polarsheath was selected to be used in a procedure.During preparation when the physician was flushing and aspirating saline through the sheath, bubbles were being pulled into the syringe.Upon inspecting the sheath it was noted that the side port looked damaged.No patient complications were reported.

Event Description

It was reported that a polarsheath was selected to be used in a procedure.However during preparation when the physician was flushing and aspirating saline through the sheath bubbles were being pulled into the syringe.Upon inspecting the sheath it was noted that the side port looked damaged.No patient complications were reported.

Manufacturer Narrative

Visual inspection of the device showed the had a puncture not connected to the slit.There was a crimp/kink in the irrigation flush line.The device did not pass hemostasis at 5.5 psi pressurization with saline, and aspiration with 10 cc and 60 cc syringes at various flowrates.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.No air bubbles were observed but the pressure decay measurements were out of specification indicating a leak from the sheath's hemostatic valve.There is no evidence this device was used in a manner inconsistent with the labeled indications.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: 10852082
• MDR Text Key: 217971645
• Report Number: 2134265-2020-15944
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025667724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Date Manufacturer Received: 12/04/2020
• Patient Sequence Number: 1