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

Model Number 86200

Device Problem Poor Quality Image (1408)

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

Event Date 09/27/2022

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 the catheter exhibited poor signal quality.During a procedure an ultra ice plus.It was noted the catheter exhibited poor signal quality.The procedure was cancelled.No patient complications were reported.The device is expected to be returned for analysis.This event is being reported for aborted/canceled procedure.

Manufacturer Narrative

The ultra ice plus catheter was returned to boston scientific for laboratory analysis.A visual inspection was performed, and the device appeared to be in good condition.Image and impedance testing were also performed.The impedance testing showed a good unit wave form, but during image characterization testing, a poor image appeared in the ilab system.A microscope inspection did not note any damage on the distal housing.Laboratory analysis confirmed the reported clinical observation.

Event Description

It was reported that the catheter exhibited poor signal quality.During a procedure an ultra ice plus.It was noted the catheter exhibited poor signal quality.The procedure was cancelled.No patient complications were reported.The device is expected to be returned for analysis.This event is being reported for aborted/canceled procedure.

• 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: 16639683
• MDR Text Key: 312283765
• Report Number: 2124215-2023-10700
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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: 0029693345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1