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

Lot Number 0029661319

Device Problems Use of Device Problem (1670); Air/Gas in Device (4062)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that during a cryoablation procedure to treat atrial fibrillation (afib), a polarsheath was selected for use.After the sheath was inserted inside the patient, the catheter was inserted into the sheath and air was confirmed during a reverse blood flow confirmation.The physician slowly applied negative pressure, but it could not be resolved even when performed several times.There was no problem after the sheath was replaced.The sheath will be returned for analysis.

Manufacturer Narrative

This polarsheath was received by boston scientific and laboratory analysis was performed.Visual inspection did not reveal any abnormalities.Standard aspiration tests performed revealed all results were within specifications.Hemostasis and air pressure testing was conducted, and the sheath met all specifications with no signs of leaking or disruption of pressure.Laboratory analysis was unable to confirm the reported clinical observations; the polarsheath passed all relevant testing.The instructions for use state "do not aspirate via the side port if the sheath lumen is occupied (i.E., by the dilator or components of the cryoablation catheter) as the aspiration may draw air across the sheath valve into the polarsheath.

Event Description

It was reported that during a cryoablation procedure to treat atrial fibrillation (afib), a polarsheath was selected for use.After the sheath was inserted inside the patient, the catheter was inserted into the sheath and air was confirmed during a reverse blood flow confirmation.The physician slowly applied negative pressure, but it could not be resolved even when performed several times.There was no problem after the sheath was replaced.The device has been received for 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: 16462410
• MDR Text Key: 310459856
• Report Number: 2124215-2023-09067
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Lot Number: 0029661319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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