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

Device Problem Material Perforation (2205)

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

Event Date 02/26/2024

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 cryo-ablation procedure using a polarmap the catheter became broken during use.During the procedure an outer balloon pressure occurred and troubleshooting ultimately required replacing the balloon catheter.The polarmap had to be removed from the original balloon catheter for the exchange.When the polarmap was loaded into the new balloon catheter the polarmap's shaft broke near the second electrode, requiring the exchange of the polarmap.The procedure was then completed with no patient complications.The polarmap is expected to be returned for analysis.

• 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: 18979974
• MDR Text Key: 338688829
• Report Number: 2124215-2024-17595
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/26/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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