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

Model Number	86200
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned there for investigation could only review reported information.A risk review of the ultra ice plus was completed, ultra ice plus hazard analysis and fmea, bsc, aj and confirmed that the event of "catheter difficult to irrigate" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.
Event or Problem Description
It was reported as the ultra ice plus was inserted into the patient, air had been introduced into the system and could not be removed.The catheter was replaced with another ultra ice.No patient complications were reported.

• Brand Name: ULTRA ICE PLUS
• Common Device Name: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10028809
• Report Number: 2134265-2020-06098
• Device Sequence Number: 19757047
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 11/21/2021
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0024812184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1