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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-14
Device Problem Entrapment of Device (1212)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Renal Failure (2041)
Event Date 08/06/2020
Event Type  Death  
Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided. Patient is over 80 years old, exact age is unknown. This report is related to the orbital atherectomy device reported under report number 3004742232-2020-00270. Csi id: (b)(4).
 
Event Description
The viperwire guide wire was selected for use in treatment of a lesion in the peroneal artery. During the first treatment pass the orbital atherectomy device and guide wire became stuck in the vessel. After several troubleshooting attempts the oad was removed, however the guide wire remained stuck and appeared mangled. Imaging was performed and revealed that the vessel had shut down due to removal of the oad. The patient had been in the procedure for approximately three to four hours. The patient was transferred to the hospital for a four-hour bypass surgery to resolve the issue and the guide wire was removed. The patient was fine on (b)(6) 2020 during a follow-up visit, however on (b)(6) 2020 the patient presented with renal failure, despite having no history of renal failure. The patient was hospitalized and expired on the same day, due to renal failure. Per the physician, the length of the two procedures combined with the vessel shut down and amount of contrast likely used throughout the procedures led to renal failure.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, mn 
2591600
MDR Report Key10491083
MDR Text Key205588742
Report Number3004742232-2020-00269
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 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVPR-GW-14
Device Catalogue Number72023-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/03/2020 Patient Sequence Number: 1
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