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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 H7493927615350
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 01/16/2017
Event Type  Death  
Manufacturer Narrative
The complaint device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
Same case as mdr id# 2134265-2017-00682, 2134265-2017-00686, and 2134265-2017-00761. It was reported that the patient died. The patient presented with myocardial infarction (mi) and angiogram was performed. One target lesion was identified as a total occlusion in the right coronary artery (rca), two small target lesions were identified in the left anterior descending (lad) artery, and a small non-dominant target lesion in the circumflex artery. After a temporary pacemaker was placed, a 5fr sheath was inserted and a 2. 50mm x 20mm emerge¿ balloon catheter was advanced and pre-dilatation was performed to the two lesions in the lad. A 2. 75 x 32 synergy¿ drug-eluting stent was then implanted in the first lad lesion and post-dilated with a 3. 50mm x 15mm nc emerge® balloon catheter. However, upon stenting of the second lad lesion with a 3. 00 x 20 synergy¿ drug-eluting stent, the patient crashed with the pressures and pulse dropped. The procedure was stopped and advanced life support (als) was performed with emergency drugs administered. The patient was unable to be recovered and subsequently passed away. The official cause of death was infarction.
 
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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 Key6331704
MDR Text Key67476763
Report Number2134265-2017-00762
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeZA
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 01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model NumberH7493927615350
Device Catalogue Number39276-1535
Device Lot Number19798393
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 Received01/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2016
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: 02/15/2017 Patient Sequence Number: 1
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