MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE

Lot Number 0028287646

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

During a cryoablation procedure, a polarsheath was selected for use.It was reported that a balloon catheter was inserted into the polarsheath and the back flow of blood was checked.A small amount of air is usually drawn in, however, a large amount of air was drawn in this time; therefore, the sheath was replaced with a new one due to the risk of air embolism.The procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

The device was received at boston scientific for analysis.Visual inspection noted blood on the handle and in the flush line.A tear was observed on the hemostatic valve.Functional tests were performed, and the device passed the aspiration and air pressure tests, but failed the hemostatic valve test as the sheath could not maintain a pressure of 5.5 psi for 30 seconds.The sheath handle was disassembled to find the area where the leak occurred.Analysis found a leak between the extension line adhesive filet and valve housing.The reported event was confirmed.

Event Description

During a pulmonary vein isolation (pvi) cryoablation procedure, a polarsheath was selected for use.It was reported that a balloon catheter was inserted into the polarsheath and the back flow of blood was checked.A small amount of air is usually drawn in, however, a large amount of air was drawn in this time; therefore, the sheath was replaced with a new one due to the risk of air embolism.The procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

The device was received at boston scientific for analysis.The sheath failed standard manufacturing testing when the sheath could not maintain a pressure of 5.5 psi for 30 seconds.The sheath handle was disassembled to find the area where the leak occurred.Analysis found a leak between the extension line adhesive fillet and valve housing.The reported clinical observation was able to be confirmed.

Event Description

During a cryoablation procedure, a polarsheath was selected for use.It was reported that a balloon catheter was inserted into the polar sheath and the back flow of blood was checked.A small amount of air was drawn in usually, however, a large amount of air was drawn in this time; therefore, the sheath was replaced with a new one due to the risk of air embolism.The procedure was completed successfully.No patient complications were reported.Sheath was returned to boston scientific for laboratory analysis.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14834461
• MDR Text Key: 300403580
• Report Number: 2134265-2022-07329
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2024

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: 09/08/2022
• Device Lot Number: 0028287646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 06/30/2022; 12/18/2023
• Supplement Dates FDA Received: 07/18/2022; 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1