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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION
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BOSTON SCIENTIFIC CORPORATION Back to Search Results
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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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 Number5
Product Code DXK
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 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
Is this an Adverse Event Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2020
Initial Date FDA Received04/14/2020
Patient Sequence Number1
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 Age69 YR
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