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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC BALLOON CATHETER MONORAIL STERLING CATHETER

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BOSTON SCIENTIFIC BALLOON CATHETER MONORAIL STERLING CATHETER Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 07/08/2016
Event Type  malfunction  
Event Description
Single use disposable instrument error. We were only notified of this error on 02/21/2018.
 
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Brand NameBALLOON CATHETER
Type of DeviceMONORAIL STERLING CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key7327179
MDR Text Key102115948
Report NumberMW5075778
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 03/07/2018
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

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