MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 0029112334

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath, it was observed that the sheath was leaking with air bubbles.It appeared that the leak was coming from the hemostatic valve.They exchanged the sheath and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

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

T was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath, it was observed that the sheath was leaking with air bubbles.It appeared that the leak was coming from the hemostatic valve.They exchanged the sheath and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received at boston scientific's post market laboratory for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the sheath was first visually inspected, and no visual abnormalities were found.Next, they functionally tested the sheath by replicating aspiration and the sheath was within specification and showed no air bubbles for each variation of the test.Then, they tested the integrity of the hemostatic valve and found the sheath was within specification for maintaining internal pressure and no leaks were observed.Based on all the available evidence the conclusion is that no problem was detected with the returned device; a the reported allegation could not be replicated, and no other issues were found with the device.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 15539230
• MDR Text Key: 305544272
• Report Number: 2124215-2022-39568
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: 02/03/2023
• Device Lot Number: 0029112334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1