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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) CORONARY PERIPHERAL DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) CORONARY PERIPHERAL DEVICE Back to Search Results
Model Number VPR-GW-FLEX14
Device Problems Unintended System Motion (1430); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/03/2020
Event Type  Injury  
Manufacturer Narrative
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. Additional information regarding the device lot number was requested, but the facility did not keep a record of the lot number, and it cannot be determined by examining the wire. (b)(4).
 
Event Description
A viperwire and diamondback pluto peripheral orbital atherectomy device were selected for use in the posterior tibial artery. Treatments were administered on low and medium speed. In the opinion of csi field staff, the physician technique was too fast. The viperwire retracted during treatment and came into contact with the oad driveshaft. The spring tip of the viperwire fractured. The viperwire was then stuck in the oad. The fragment was removed with a snare, and the vessel was rewired. The procedure was completed with angioplasty. The patient was discharged later the same day and did not report any sequelae.
 
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Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
Type of DeviceCORONARY PERIPHERAL DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul, mn
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, mn 
MDR Report Key10476287
MDR Text Key205099707
Report Number3004742232-2020-00262
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVPR-GW-FLEX14
Device Catalogue Number7-10041-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2020 Patient Sequence Number: 1
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