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

Lot Number 0029976138

Device Problems Detachment of Device or Device Component (2907); Air/Gas in Device (4062)

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

Event Date 11/08/2022

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

It was reported that during a pulmonary vein isolation procedure to treat atrial fibrillation a polarsheath was selected for use.It was noted that the side port used for flushing was constricted and loose, multiple air bubbles occurred.The sheath was replaced and the procedure was completed.There were no patient complications.The sheath is expected to be returned for laboratory analysis.

Event Description

It was reported that during a pulmonary vein isolation procedure to treat atrial fibrillation a polarsheath was selected for use.It was noted that the side port used for flushing was constricted and loose, multiple air bubbles occurred.The sheath was replaced, and the procedure was completed.There were no patient complications.The sheath has been returned for laboratory analysis.

Manufacturer Narrative

The polarsheath steerable sheath was returned to boston scientific for analysis.Visual inspection revealed a kink in the flush line, no other abnormalities were noted.Standard aspiration tests performed revealed all results were within specifications.No bubbles were visible in the flushing line during test/syringe vacuum.Hemostasis testing was conducted, and the sheath met all specifications with no signs of leaking or disruption of pressure.The catheter failed air pressure testing for location of leaks.The sheath handle was disassembled to find the area where the leak occurred.No leak was found.Laboratory analysis was able to confirm the reported clinical observations regarding visible air/bubbles.The reported field observation for detachment of device or device component was not confirmed.The flush line on the side port was found to be kinked, but no loose components were observed.B.

• 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: 15835307
• MDR Text Key: 307095914
• Report Number: 2124215-2022-47940
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Lot Number: 0029976138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1