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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS CORPORATION VIPER WIRE ADVANCE CATHETER, PERIPHERAL, ATHERECTOMY

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CARDIOVASCULAR SYSTEMS CORPORATION VIPER WIRE ADVANCE CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number GWC-12312LG-FLP
Device Problems Difficult to Insert (1316); Material Separation (1562); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/26/2020
Event Type  Injury  
Event Description
A (b)(6) male patient with complaints of worsening chest pain presented to (b)(6) for cardiac catheterization on (b)(6) 2020. A diffused and calcified disease of the rca with multiple critical stenosis was noted. A successful balloon angioplasty was performed to the ostial rca. However, several attempts were made to pass the balloon across the proximal stenosed rca were unsuccessful. The wire is unable to pass the atherectomy device past the ostium of rca. When attempting to remove the atherectomy burr, the distal tip of the wire severed and was lodged in the minuscule acute marginal branch. No intervention was made to the retained wire. Fda safety report id# (b)(4).
 
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Brand NameVIPER WIRE ADVANCE
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS CORPORATION
st. paul MN
MDR Report Key10748449
MDR Text Key213880594
Report NumberMW5097503
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 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGWC-12312LG-FLP
Device Lot Number11189137
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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