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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS CATHETER, ULTRASOUND, INTRACARDIAC Back to Search Results
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.
 
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Brand NameULTRA ICE PLUS
Type of DeviceCATHETER, 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 Key9957114
MDR Text Key187556274
Report Number2134265-2020-05058
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received04/14/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date05/14/2021
Device Model Number86200
Device Catalogue Number86200
Device Lot Number0023798185
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 04/14/2020 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
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