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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Back to Search Results
Model Number VPR-GW-FT14
Device Problems Entrapment of Device (1212); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/20/2018
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. Csi id: (b)(4).
 
Event Description
Difficulty was encountered during advancement of the viperwire into the distal anterior tibial artery. The vessel exhibited 100% stenosis, and the lesion of interest was type b. Seven treatments were completed with the orbital atherectomy device (oad). During the last treatment, the oad became stuck but was eventually retracted. Difficulty was encountered during removal of the viperwire since it was stuck in a calcified region of the vessel. During attempts to remove the wire, it fractured. The intact portion of the wire was removed, the vessel was re-wired, and the procedure was continued. The fragment was left in vivo, and a stent was used to fix the fragment to the vessel wall. The procedure concluded with good results and the patient was stable.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DeviceDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key8195960
MDR Text Key131391078
Report Number3004742232-2018-00380
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151260
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 01/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberVPR-GW-FT14
Device Catalogue NumberVPR-GW-FT14
Device Lot Number234376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2018
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: 12/26/2018 Patient Sequence Number: 1
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