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

Model Number	86200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: (b)(6).It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
Interrupt af clinical study.Following an ablation procedure with an intellamap orion high resolution mapping catheter, two ultra ice plus catheters, an intellanav mifi open-irrigated catheter and a polaris x steerable diagnostic catheter, the patient was hospitalized due to a complaint of chest pain.The patient was given intravenous (iv) furosemide 40mg, methylprednisolone (solu-medrol) 125mg and lorazepam (ativan) 0.5mg and the event resolved.No further information was provided.

• 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: 9957114
• Report Number: 2134265-2020-05058
• Device Sequence Number: 11412065
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0023798185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLANAV MIFI OPEN-IRRIGATED CATHETER; POLARIS X STEERABLE DIAGNOSTIC CATHETER; ULTRA ICE PLUS CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR