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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493927606400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)
Event Date 05/04/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2018-04654, 2134265-2018-04655, 2134265-2018-04656, 2134265-2018-04646, 2134265-2018-04659, 2134265-2018-04660. It was reported that vessel perforation and cardiac tamponade occurred. The patient presented with diffused calcification and narrowing of the left main (lm), left anterior descending (lad) and left circumflex (lcx); severe left ventricle (lv) dysfunction and aortic stenosis. This procedure was planned prior to an a transcatheter aortic valve implantation. Pre-dilation was completed with emerge¿ balloon catheters. Then three synergy¿ stents were implanted (4 x 24, 4 x 28 and a 3. 5 x 38) were implanted. The stents were post dilated with nc emerge® balloon catheters. After post dilatation, a perforation was noted at the bifurcation of the lad and lcx. The perforation was treated by deploying non-bsc stents and further post dilatation of those stents. The perforation caused cardiac tamponade and pericardiocentesis was performed; a significant amount of blood was drained. The patient was stable prior to transfer to the intensive care unit.
 
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Brand NameNC EMERGE®
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7506071
MDR Text Key107963490
Report Number2134265-2018-04647
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
SIMILAR
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 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2020
Device Model NumberH7493927606400
Device Catalogue Number39276-0640
Device Lot Number21687892
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 Received05/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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: 05/11/2018 Patient Sequence Number: 1
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