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

Lot Number 0031172598

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

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

The polarsheath was selected for use during the cryocoagulation myocardial ablation to treat paroxysmal atrial fibrillation.It was reported that air was drawn in through the hemostatic valve when backflow of blood was drawn from the three-way stopcock attached to the polarsheath while the polarx balloon catheter was inserted.Additionally, air bubbles were seen intermittently from the side port to the backflow of blood was drawn from syringe.A new polarsheath was used, and no air retraction occurred.The procedure was completed successfully.No patient complication was reported.The device has been returned for analysis.

Event Description

The polarsheath was selected for use during the cryocoagulation myocardial ablation to treat paroxysmal atrial fibrillation.It was reported that air was drawn in through the hemostatic valve when backflow of blood was drawn from the three-way stopcock attached to the polarsheath while the polarx balloon catheter was inserted.Additionally, air bubbles were seen intermittently from the side port to the backflow of blood was drawn from syringe.A new polarsheath was used, and no air retraction occurred.The procedure was completed successfully.No patient complication was reported.The device has been returned for analysis.

Manufacturer Narrative

The returned polarsheath was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported allegation of visible air/bubbles was not confirmed.Per complaint summary it was confirmed that an attempt to aspirate the polarsheath with the catheter occupying the sheath lumen occurred.This is inconsistent with the labelled indications/ifu.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

• 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: 17231698
• MDR Text Key: 318178063
• Report Number: 2124215-2023-29681
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Lot Number: 0031172598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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