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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. PTCA DILATATION CATHETER NC EMERGE MONORAIL 2.50 MM X 20 MM CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORP. PTCA DILATATION CATHETER NC EMERGE MONORAIL 2.50 MM X 20 MM CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number H7493926720250
Device Problem Separation Problem (4043)
Patient Problem Stenosis (2263)
Event Date 11/07/2018
Event Type  Injury  
Event Description
Pt was admitted for chest pain and acute mi on (b)(6) 2018. He underwent cardiac catheterization. An area of stenosis was stented. During post dilation of the stent segment, the balloon catheter separated upon inflation leaving behind the distal shaft, including the guide wire, in the right coronary artery. Ct confirmed catheter tip location. The event was disclosed to pt and his wife and plan for emergency cardiac surgery. Pt was taken to the operating room for retrieval of retained device and also underwent aortocoronary bypass grafting x 5 for diffuse 4 -vessel coronary artery disease. Pt was discharged on (b)(6) 2018 to an inpatient rehabilitation facility where he stayed until (b)(6) 2018. He was reported to be doing well during last office visit on (b)(6) 2018.
 
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Brand NamePTCA DILATATION CATHETER NC EMERGE MONORAIL 2.50 MM X 20 MM
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
MDR Report Key8160246
MDR Text Key130324752
Report NumberMW5082068
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberH7493926720250
Device Lot Number22732903
Was Device Available for Evaluation? Yes
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: 12/12/2018 Patient Sequence Number: 1
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