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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-125MICRO145
Device Problem Unintended System Motion (1430)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2019
Event Type  malfunction  
Manufacturer Narrative
The reported oad was received at csi for analysis. No damage was observed on the device. The device was turned on and off numerous times with no issues observed. While performing functional testing, the power cord, brake and control knob were manipulated, and no issue was noted. At the conclusion of the device analysis investigation, the report that the oad shut down and began operating independently could not be confirmed as the oad functioned as intended during the analysis. The device history record for this oad lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements prior to distribution. Csi id: (b)(4).
 
Event Description
During treatment of a 90% stenosed lesion in the proximal anterior tibial artery with a diamondback peripheral orbital atherectomy device (oad), the motor stalled and the device lost power. The oad then started operating again independently. The device was turned off by the physician and removed from the patient. The device was unplugged and reconnected to the saline pump, however the issue was unable to be resolved. The patient was doing well following the procedure.
 
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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 Key9010423
MDR Text Key191588763
Report Number3004742232-2019-00243
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberDBP-125MICRO145
Device Catalogue NumberDBP-125MICRO145
Device Lot Number273960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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