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

Lot Number 0030179918

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

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

Event Date 11/15/2022

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 (pvi) procedure treat atrial fibrillation (a fib), a polarsheath steerable sheath was selected for use.It was reported that after inserting the polarx balloon catheter into the sheath, it was difficult to draw back the blood.Furthermore, air was confirmed at the side port of the sheath a little after the balloon catheter was removed from the sheath in the left atrium.The air was checked, one after another even though air was drawn with a syringe.It was determined that the sheath was defective; therefore, the sheath was replaced with a sheath from a different lot; but there was no improvement.The balloon catheter was replaced with another lot, but the same problem occurred, so the procedure was completed using a non-boston scientific radio frequency catheter.No patient complications were reported.Polarsheath devices are expected to be returned.

Event Description

During a pulmonary vein isolation (pvi) procedure treat atrial fibrillation (a fib), a polarsheath steerable sheath was selected for use.It was reported that after inserting the polarx balloon catheter into the sheath, it was difficult to draw back the blood.Furthermore, air was confirmed at the side port of the sheath a little after the balloon catheter was removed from the sheath in the left atrium.The air was checked, one after another even though air was drawn with a syringe.It was determined that the sheath was defective; therefore, the sheath was replaced with a sheath from a different lot; but there was no improvement.The balloon catheter was replaced with another lot, but the same problem occurred, so the procedure was completed using a non-boston scientific radio frequency catheter.No patient complications were reported.Polarsheath devices are expected to be returned.

Manufacturer Narrative

The polarsheath steerable sheath was returned and analyzed.The reported allegation for visible air/bubbles was not confirmed.Visual inspection presented no abnormalities.The sheath passed all standard manufacturing testing and was able to hold pressure while pressurized at 5.5 psi in hemostasis testing.The ifu states "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

During a pulmonary vein isolation (pvi) procedure treat atrial fibrillation (a fib), a polarsheath steerable sheath was selected for use.It was reported that after inserting the polarx balloon catheter into the sheath, it was difficult to draw back the blood.Furthermore, air was confirmed at the side port of the sheath a little after the balloon catheter was removed from the sheath in the left atrium.The air was checked, one after another even though air was drawn with a syringe.It was determined that the sheath was defective; therefore, the sheath was replaced with a sheath from a different lot; but there was no improvement.The balloon catheter was replaced with another lot, but the same problem occurred, so the procedure was completed using a non-boston scientific radio frequency catheter.No patient complications were reported.Product has been returned and analysis has been performed.

• 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: 15959065
• MDR Text Key: 307983978
• Report Number: 2124215-2022-48062
• 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,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

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: 08/01/2023
• Device Lot Number: 0030179918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 01/20/2023
• Supplement Dates FDA Received: 01/12/2023; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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