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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 PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number VPR-GW-FT14
Device Problems Material Separation (1562); Noise, Audible (3273)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
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
The viperwire fractured following an unusual audible noise heard during the procedure in the superior femoral artery, which was 40-70% stenosed. The wire fragment was located in the external illiac artery, but attempts to remove the fragment over the next two hours were unsuccessful. A hematoma formed at the access site. Anticoagulants were administered to the patient and the fragment was then surgically removed. The patient was discharged home the following day.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
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 Key8206073
MDR Text Key131708546
Report Number3004742232-2018-00394
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,Followup,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberVPR-GW-FT14
Device Catalogue NumberVPR-GW-FT14
Device Lot Number238076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2018
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: 12/31/2018 Patient Sequence Number: 1
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