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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 H7493927615400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 10/20/2017
Event Type  Death  
Manufacturer Narrative
Age at time of event: 18 years or older. 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 mdrs# 2134265-2017-10914, 2134265-2017-10915, 2134265-2017-10916, 2134265-2017-10918, 2134265-2017-10920, 2134265-2017-10930, 2134265-2017-10932, 2134265-2017-10933, 2134265-2017-10934. It was reported that patient death occurred. The target lesion was located in the left main (lm) to mid left anterior descending artery (lad). The lm to mid lad were rotablated successfully using a 1. 75 rotalink burr, a rotalink advancer, and a 300 cm rotawire per the directions for use (dfu). The lesion was dilated with a 3. 0x20mm nc emerge® balloon. A 3. 0x20mm synergy¿ stent was introduced but failed to cross the mid lad lesion. The lesion was dilated with a 3. 5x20mm nc emerge® balloon and the same 3. 0x20mm synergy¿ stent was successfully delivered. A 3. 0x24mm synergy¿ stent was deployed in the proximal lad and a 4. 0x20mm promus premier¿ stent was deployed in the proximal lad into the lm. A new 3. 5x20mm nc emerge® balloon was used to post dilate the stents in the lad and a 4. 0x15mm nc emerge® balloon was used to post dilate the promus premier¿ stent in the lm. While the 4. 0x15mm nc emerge® balloon was being inflated briefly, the patient complained of chest pain. The physician did a final inflation at the very proximal end of the promus premier¿ stent. As the physician took a cine of the final result, the patient's blood pressure dropped and the patient became non responsive. A medical emergency was called but the patient died.
 
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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 Key7010921
MDR Text Key91408048
Report Number2134265-2017-10917
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 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493927615400
Device Catalogue Number39276-1540
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 Received10/20/2017
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: 11/08/2017 Patient Sequence Number: 1
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