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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Thrombosis (2100)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: the event date was not provided. The first date of the month of the aware date was used.
 
Event Description
It was reported that chest pain and acute thrombosis occurred. The target lesion was located in the mid circumflex artery. After dilatation with a 2. 25x15mm emerge balloon catheter, a 3. 00x24mm synergy ii drug-eluting stent was deployed. A 3. 25mm x 12mm nc emerge balloon catheter was then advanced to perform post dilatation. However, during the first inflation, the patient started complaining of chest pain. Upon observation of the stent, it was noted that the stent had thrombus at the distal end. The issue was identified to be an irregular shape of the stent. The physician assumed as stent fracture. After a number of post dilatations, the stent looks good and the physician was happy with the result. No further patient complications were reported and the patient's status was stable.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7967264
MDR Text Key123795401
Report Number2134265-2018-61923
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/03/2020
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0021944298
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 Received10/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2018
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: 10/15/2018 Patient Sequence Number: 1
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