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

Model Number 86200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 02/01/2020

Event Type  Injury  

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 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
• 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: 9957114
• MDR Text Key: 187556274
• Report Number: 2134265-2020-05058
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2020
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLANAV MIFI OPEN-IRRIGATED CATHETER; POLARIS X STEERABLE DIAGNOSTIC CATHETER; ULTRA ICE PLUS CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR