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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NC EMERGE MONORAIL PCA DILATATION CATHETER

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BOSTON SCIENTIFIC NC EMERGE MONORAIL PCA DILATATION CATHETER Back to Search Results
Catalog Number H7493926712250
Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/04/2017
Event Type  Injury  
Event Description
A (b)(6) patient was undergoing a complex pci and a coronary balloon ruptured in the patient's coronary artery. Balloon became dislodged in the coronary artery. Md was able to snare the balloon and remove it from the coronary artery, however while proceeding down the aorta with the snared balloon, it became lodged in one of the patients abdominal arteries. The balloon location was verified under fluoroscopy imaging. Balloon fragments remain as a retained foreign object.
 
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Brand NameNC EMERGE MONORAIL
Type of DevicePCA DILATATION CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC
marlborough MA 01752
MDR Report Key6776728
MDR Text Key82376250
Report NumberMW5071448
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/21/2019
Device Catalogue NumberH7493926712250
Device Lot Number20910503
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
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