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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

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.

Event Description

During a pulmonary vein isolation procedure to treat paroxysmal atrial fibrillation a polarsheath was selected for use.An 8-french blazer catheter was introduced into the sheath in order to ablate the cavo-tricuspid isthmus line.It was reported that a blood-saline mix was leaking from the hemostatic valve after the sheath was pulled back into the right atrium.The procedure was completed successfully with no patient complications or exchanging the device.Post procedure, a small crack was observed in the valve.

Event Description

During a pulmonary vein isolation procedure to treat paroxysmal atrial fibrillation a polarsheath was selected for use.An 8-french blazer catheter was introduced into the sheath in order to ablate the cavo-tricuspid isthmus line.It was reported that a blood-saline mix was leaking from the hemostatic valve after the sheath was pulled back into the right atrium.The procedure was completed successfully with no patient complications or exchanging the device.Post procedure, a small crack was observed in the valve.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection noted a kink in the flushline.There was a small tear/puncture appearing on the outer slit of the hemostatic valve.The device passed various pressure decay, aspiration, and hemostasis testing at various flow rates.The device did not pass aspiration testing after the polarx surrogate or dilator were removed.There is no evidence to suggest that 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.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 (b)(6) 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.

• 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: 11307460
• MDR Text Key: 232541493
• Report Number: 2134265-2021-01529
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025535399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 03/31/2021
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1