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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC Back to Search Results
Model Number M00499120
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 07/14/2017
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older. Device evaluated by manufacturer: the complaint device was not returned for evaluation. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that patient pericardial effusion occurred. The target lesion was located in the right and left atrium. During and atrial fibrillation ablation procedure and ultra ice plus¿ was used. The physician felt the ice images had poor quality and the physician described the patient as having a thick septum and thought that might have contributed to the poor images. The patient experienced a pericardial effusion that required surgical intervention. They aborted the procedure due to this event. Patient is now stable and doing well.
 
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Brand NameULTRA ICE PLUS¿
Type of DeviceCATHETER, ULTRASOUND, INTRACARDIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6795253
MDR Text Key82723601
Report Number2134265-2017-07872
Device Sequence Number1
Product Code DXK
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 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM00499120
Device Catalogue Number9912
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 Received07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/15/2017 Patient Sequence Number: 1
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