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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

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.To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.

Event Description

It was reported that during a procedure involving a polarsheath device the cap on back of the handle detached.When a balloon catheter that was inserted though the polarsheath was removed, the valve of the sheath began to leak.The polarsheath could not be used to continue with rf (radiofrequency) ablation.No patient complications were reported.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.Device technical analysis visual inspection of the device showed the end cap of the sheath was detached and not returned with device.There were no obvious tears/punctures appearing on the outer slit of the hemostatic.The device passed both the normal and extensive engineering aspiration and hemostasis testing.The device also passed the air pressure test for leaks.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.

Event Description

It was reported that during a procedure involving a polahsheath device the cap on back of the handle detached.When a balloon catheter that was inserted though the polarsheath was removed, the valve of the sheath began to leak.The polarsheath could not be used to continue with rf (radiofrequency) ablation.No patient complications were reported.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

• 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: 11711980
• MDR Text Key: 249325332
• Report Number: 2134265-2021-05174
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026287706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 06/09/2021
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1