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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
Event Date 04/24/2019
Event Type  Injury  
Event Description
It was reported that vessel dissection occurred.The target lesion was located in the left anterior descending artery.An nc emerge balloon catheter was advanced for post-dilatation.However, a dissection on the proximal edge of the stent occurred.The procedure was completed with by placing another stent.No further patient complications were reported and the patient's status was fine.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, 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 Key8620578
MDR Text Key145398582
Report Number2134265-2019-05333
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/17/2019
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/25/2019
Initial Date FDA Received05/17/2019
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
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