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

Model Number M004CRBS3050

Device Problem Difficult to Flush (1251)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2020

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

It was reported that during a cryoablation procedure for paroxysmal atrial fibrillation, prior to ablation, after insertion of the polarx balloon catheter into the polarsheath, the irrigation no longer worked properly.The physician pulled out the catheter, and aspirated and flushed the sheath again.However, the irrigation issue persisted.The issue only occurred when the catheter shaft was inside the polarsheath.There were no patient complications and the procedure was completed with the same device.The device is expected to be returned for analysis.

Manufacturer Narrative

The device was returned to boston scientific for analysis.During initial inspection, there was no visible tears on the outer slit of the hemostatic valve seal.The device passed the pressure decay test at 6 psi, the hemostasis test at 5.5 psi pressurization with saline, and the aspiration test with 10 cc and 60 cc syringe at various flowrates.Additional aspiration and hemostasis testing was conducted with a polarx catheter inserted in the polarsheath to further evaluate the hemostatic valve limits under induced manipulation.Some air bubbles and leaking was observed when the polarx test catheter was inserted into the sheath and tipped at various angles; however, there were no air bubbles/leaking noted once the catheter was removed, indicating the hemostatic valve maintained appropriate integrity.Laboratory analysis did not identify any product characteristics that would have resulted in the reported irrigation difficulties.Occlusion of the sheath by the catheter would result in a temporary flow reduction until the catheter was pushed through the sheath into the left atrium.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that during a cryoablation procedure for paroxysmal atrial fibrillation, irrigation through the polarsheath no longer worked properly after the polarx balloon catheter was inserted.The physician pulled out the catheter, and aspirated, and flushed the sheath again; however, the irrigation problem persisted.The issue only occurred when the catheter shaft was inside the polarsheath.There were no patient complications and the procedure was completed with the same device.The device was returned for analysis.

• 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: 10521048
• MDR Text Key: 207620778
• Report Number: 2134265-2020-12632
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025710272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 11/20/2020
• Patient Sequence Number: 1