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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC. SMITHWICK CAROTID SHUNT CLAMP VASCULAR

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IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC. SMITHWICK CAROTID SHUNT CLAMP VASCULAR Back to Search Results
Catalog Number REF 70-001-0028
Device Problem Inflation Problem (1310)
Patient Problem No Information (3190)
Event Date 06/09/2018
Event Type  malfunction  
Event Description
Lot # cso13118-02 balloon could not be inflated. Lot # cs0 80116-01 also difficult to inflate one of the balloons.
 
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Brand NameSMITHWICK CAROTID SHUNT
Type of DeviceCLAMP VASCULAR
Manufacturer (Section D)
IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC.
MDR Report Key8428351
MDR Text Key139217996
Report NumberMW5084960
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/14/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received03/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberREF 70-001-0028
Device Lot NumberCS080116-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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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