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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 DBP-EX-200SOL145
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Event Date 10/14/2021
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. Additional event information has been requested. If received, a supplemental report will be submitted. The device history record for the reported oad was unable to be reviewed, as the lot number was not provided. Csi id: (b)(4).
 
Event Description
A diamondback peripheral exchangeable orbital atherectomy device (oad) was used to treat a heavily calcified, 95% stenosed lesion in the left common iliac. During a treatment pass on medium speed, the patient became hypotensive. Imaging was performed and extravasation was noted and determined to be a perforation. The oad was removed and an attempt was made to insert an additional guide wire. A covered stent was inserted but was unable to control the bleeding. As the bleeding was unable to be controlled from an endovascular approach, the physician performed a cut down procedure to perform further intervention. The bleeding was unable to be controlled and the patient expired.
 
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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
st. paul, mn MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul, mn MN 55112
Manufacturer Contact
laramie otto
1225 old highway 8 nw
st. paul, mn, MN 55112
6512591600
MDR Report Key12816518
MDR Text Key280787210
Report Number3004742232-2021-00374
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDBP-EX-200SOL145
Device Lot Number346405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
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: 11/15/2021 Patient Sequence Number: 1
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