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

Lot Number 0030579049

Device Problem Difficult to Advance (2920)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

Crbs polarmap catheter 20mm was evaluated by boston scientific.Upon device return, it was observed that the polarmap was kinked/fractured.A functional test was successfully performed by fully advancing the polarmap through a known good polarx device.However, the observed kink/fracture could potentially cause unusual resistance and result in a more difficult advancement of the polarmap.Laboratory analysis was able to confirm the reported clinical observation.

Event Description

Complaint is reportable per product investigation analysis results.It was reported that during a procedure to treat an atrial fibrillation (af), a polarmap catheter was selected for use.It was reported that the polarmap catheter is inside of the polarx balloon catheter, the feeling was not good, the polarmap catheter didn't advance correctly through the polarx balloon catheter.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Upon device analysis, it was noted that the catheter is fractured.

• Brand Name: POLARMAP
• 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: 17139748
• MDR Text Key: 317343385
• Report Number: 2124215-2023-29851
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 06/15/2023

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: 11/21/2023
• Device Lot Number: 0030579049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1