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

Model Number	86200
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2023-13213
• Device Sequence Number: 14590403
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2024
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown