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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
Model Number H7493926712300
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2019
Event Type  malfunction  
Event Description
Unable to deliver side by side through 6fr launcher ar2 guiding catheter with 2. 0x 12mm. Euphora balloon (not nc euphora) over prowater guidewire: resistance in 1-degree + 2-degree curve. Pulled out and shaft broke. Second such event in 2 days. Unclear if same lot number.
 
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Brand NameNC EMERGE®
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed way
maple grove MN 55311
MDR Report Key9537777
MDR Text Key173291535
Report Number9537777
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493926712300
Device Catalogue NumberH7493926712300
Device Lot Number23593807
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2019
Event Location Hospital
Date Report to Manufacturer01/02/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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