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 11/29/2021

Event Type  malfunction  

Event Description

During an ablation to treat left atrial flutter a ultra ice plus catheter and rhythmia mapping system were selected for use.It was reported that poor ultrasound imaging/noise was observed during the procedure.The catheter was replaced, however, the transeptal puncture was unsuccessful.The procedure was aborted.Further troubleshooting indicated that the cause of the noise was the rhythmia signal station.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 13078452
• MDR Text Key: 282725573
• Report Number: 2134265-2021-16174
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0027756703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RHYTHMIA HDX MAPPING SYSTEM