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 09/25/2020

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

During a cryoablation procedure for atrial fibrillation, a polarsheath was selected for use.It was reported that at the end of the procedure, blood was leaking distally from the hemostatic valve.The sheath was almost removed from the patient, with the distal end facing downwards when the leak was observed.The procedure was completed successfully without exchanging devices and no patient complications were reported.

Event Description

During a cryoablation procedure to atrial fibrillation, a polarsheath was selected for use.It was reported that at the end of the procedure, blood was leaking out distally from the hemostatic valve.The sheath was almost removed from the patient, with the distal end facing downwards when the leak was observed.The procedure was completed successfully without exchanging the sheaths and no patient complications were reported.

Manufacturer Narrative

Microscopic visual inspection revealed that the valve seal had a tear on the topside of the slit and a hole coming from the backside of the outer slit.The device did not pass pressure decay at 6 psi, hemostasis at 5.5 psi pressurization with saline, and aspiration with 10 cc and 60 cc syringe at various flowrates and extensive testing.The device did not pass aspiration testing post after a dilator or polarx test catheter was removed from the sheath.The device also did not pass hemostasis testing when the polarx test catheter was tipped at an angle while inserted into the sheath.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.Laboratory analysis confirmed that the tear and hole in the hemostatic valve 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.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.

• 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: 10651891
• MDR Text Key: 211875721
• Report Number: 2134265-2020-13923
• 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

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025682407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 11/20/2020
• Patient Sequence Number: 1