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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE CORONARY GUIDE WIRE CATHETER, PERIPHERAL, ATHERECTOMY

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CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE CORONARY GUIDE WIRE CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Lot Number 11191658
Device Problems Break (1069); Migration (4003)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/28/2021
Event Type  malfunction  
Event Description
While performing orbital atherectomy in lad, tip of wire broke off and traveled into the small septal branch where it remains. Fda safety report id# (b)(4).
 
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Brand NameVIPERWIRE ADVANCE CORONARY GUIDE WIRE
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8nw
MO 55112
MDR Report Key11278683
MDR Text Key230472493
Report NumberMW5099208
Device Sequence Number1
Product Code MCW
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 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Lot Number11191658
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: 02/03/2021 Patient Sequence Number: 1
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