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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK731
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Thrombosis (2100)
Event Date 02/09/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as: 2134265-2017-01780 and 2134265-2017-01781. It was reported that thrombosis and cardiac arrest occurred. The patient presented with an inferior st elevated myocardial infarction, low blood pressure of 86/66 and was beginning to decompensate. Imaging showed an occlusion in the proximal right coronary artery (rca). The patient was given blood thinning medication and proceeded to surgical intervention. A 2. 50x20 emerge balloon catheter was advanced to the lesion and used for predilation. A 3. 00x16 synergy ii stent delivery system was advanced to the rca and deployed. At this time the patient was intubated and a code was called. Return of spontaneous circulation was established, however there was no blood flow in the rca and it appeared that stent thrombosis had occurred while the patient was in cardiac arrest. The 2. 50x20 emerge balloon catheter was again advanced and inflated in the rca. A 2. 50x24 synergy ii stent was then placed in the mid rca. The patient coded again and an automatic chest compression system was used for 2 minutes. Return of spontaneous circulation was again established. Angiography was performed and the stents were patent. A balloon pump was placed and the patient was transferred out of surgery. No additional patient complications were reported.
 
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Brand NameEMERGE
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 Key6388752
MDR Text Key69402689
Report Number2134265-2017-01778
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
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 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK731
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 Received02/14/2017
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: 03/08/2017 Patient Sequence Number: 1
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