MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number 86200

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

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that during the preparation of a myocardial ablation procedure to treat an atrial tachycardia, an ultra ice plus catheter was selected for use.There was a leak when injecting water into the tip, and when the tip was checked, it was damaged.There was a crack at the tip, and water seemed to be leaking from that part.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter is expected to be returned for further analysis.

Manufacturer Narrative

Ultra ice plus catheter was evaluated by boston scientific.No visual damages were encountered upon visual inspection.Functional inspection was performed, and a leak was observed on the tip.A microscope inspection was done and the tip was observed torn.Also, the distal housing was observed completed and no damages were observed.Laboratory analysis was able to confirm the reported clinical observations.

Event Description

It was reported that during the preparation of a myocardial ablation procedure to treat an atrial tachycardia, an ultra ice plus catheter was selected for use.There was a leak when injecting water into the tip, and when the tip was checked, it was damaged.There was a crack at the tip, and water seemed to be leaking from that part.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter was returned to boston scientific for laboratory analysis.

• Brand Name: ULTRA ICE PLUS
• Type of Device: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16629697
• MDR Text Key: 312229307
• Report Number: 2124215-2023-13213
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160173
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0030544238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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