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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 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
The reported oad was received at csi for analysis. Visual examination did not reveal any damage. The device was turned on and off numerous times with no issues observed. While performing function testing, the motor cable set, start switch and potted pcb were soaked with saline solution and the power button was activated with no unintended spinning observed. The oad was turned off and rested without the oad turning back on. There were no visible leak paths, and no damage to the start switch cables or the cable retainer. Further examination revealed there was no damage to the motor, cable set, brake or speed switch ribbons and no damage observed that would have contributed to the reported event. At the conclusion of the device analysis, the reported event that the oad spun independently without being prompted could not be confirmed as the oad functioned as intended during 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. Csi id# (b)(4).
 
Event Description
The peripheral diamondback orbital atherectomy device (oad) spun independently without being prompted. During testing outside of the body, the oad intermittently started and stopped spinning and the saline infusion pump was used to troubleshoot the issue. After 2 to 3 seconds the oad spun without being prompted at 60,000 rpms for approximately 2 to 3 seconds before becoming caught on sterile towels in the field. The device was replaced with a second oad to complete the procedure with no major delays. The patient was discharged without any complications.
 
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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 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key9197898
MDR Text Key191589386
Report Number3004742232-2019-00269
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
Report Date 10/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberDBP-125MICRO145
Device Catalogue NumberDBP-125MICRO145
Device Lot Number281367
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2019
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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