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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 02/25/2022

Event Type  malfunction  

Event Description

It was reported that a polarsheath was used in a atrial fibrillation catheter ablation procedure.During the procedure after the device was inserted inside the body, and when asperation was performed after removing the dilator, air was observed and the physician suspected that there was an issue with the hemostatic valve.The catheter was exchanged and the procedure was completed with no patient complications.

Manufacturer Narrative

Visual inspection of the device showed blood on handle and in sheath.The sheath did not present any issues related to flow or leakage.There weren't any signs that the uncontrolled tear on the surface would cause any leaks.The sheath passed aspiration, hemostasis valve and air pressure tests.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

It was reported that a polarsheath was used in a atrial fibrillation catheter ablation procedure.During the procedure after the device was inserted inside the body, and when asperation was performed after removing the dilator, air was observed and the physician suspected that there was an issue with the hemostatic valve.The catheter was exchanged and the procedure was completed with no patient complications.

• Brand Name: POLARSHEATH
• 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: 13892504
• MDR Text Key: 295793992
• Report Number: 2134265-2022-03384
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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: 08/02/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0028060815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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