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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a polarsheath was used in a pulmonary vein isolation (pvi) ablation procedure.While preparing the sheath with saline and then aspirating the saline from a bowl.The sideport of the three-way stopcock was closed after it was flushed.When aspirating saline air bubbles were being sucked in and visible in the syringe.The sheath was replaced and the procedure was completed without patient complications being reported.

Event Description

T was reported that a polarsheath was used in a pulmonary vein isolation (pvi) ablation procedure.While preparing the sheath with saline and then aspirating the saline from a bowl.The sideport of the three-way stopcock was closed after it was flushed.When aspirating saline air bubbles were being sucked in and visible in the syringe.The sheath was replaced and the procedure was completed without patient complications being reported.

Manufacturer Narrative

The returned device does have the irrigation flush-line was kinked.This causes issues in aspiration and other irrigation related testing.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.

Manufacturer Narrative

Visual examination of the returned polarsheath noted that the irrigation flush-line was kinked.A tear/puncture was also noted on the valve seal.The device passed pressure decay testing at 6 psi, hemostasis testing at 5.5 psi pressurization with saline, and aspiration testing with 10 cc and 60 cc syringe at various flowrates.The device did not pass aspiration testing when a polarx test catheter was inserted, withdrawn, or when tipped at slight angles (relative to the sheath).The device also did not pass hemostasis testing when a polarx test catheter was inserted or when tipped at slight angles (relative to 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; the measurements were within the acceptable range and no air bubbles were observed.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

T was reported that a polarsheath was used in a pulmonary vein isolation (pvi) ablation procedure.While preparing the sheath with saline and then aspirating the saline from a bowl.The sideport of the three-way stopcock was closed after it was flushed.When aspirating saline, air ingress was observed, as air bubbles were visible in the syringe.The sheath was replaced and the procedure was completed without patient complications being reported.

• 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: 10809329
• MDR Text Key: 217171680
• Report Number: 2134265-2020-15525
• 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,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/18/2020; 02/26/2021
• Supplement Dates FDA Received: 01/12/2021; 03/22/2021
• Patient Sequence Number: 1