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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-200SOLID145
Device Problem Unexpected Shutdown (4019)
Patient Problems Embolism (1829); Vascular System (Circulation), Impaired (2572)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
The reported oad was received at csi for analysis. Visual examination of the saline sheath revealed a hole at the nose cone area, and that the sheath was kinked and damaged. The driveshaft had fractured filars near the lap weld. Both the driveshaft filars and the driveshaft appeared damaged and deformed. There was adhered polyimide material located in the area of the fractured filars. This adhered material was the result of the damaged, driveshaft filars spinning within the polyimide tubing. The polyimide material was not considered a contributing factor to the reported event. Scanning electron microscopy analysis of the fractured driveshaft sections revealed fatigue striations. The exact root cause could not be determined, however it was hypothesized that the sheath and driveshaft filar damage were the result of localized, elevated stress levels that were applied to the sheath and driveshaft while spinning. Similar sheath and shaft damage has been observed by applying a bend or kink at the nose cone and glue plug area while the device was spinning. This can cause enough force to result in saline sheath separation, and driveshaft filar fractures. When tested, the oad spun on all speeds and all led lights illuminated as expected. At the conclusion of the device analysis, the reported event could not be confirmed. 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. (b)(4).
 
Event Description
The peripheral diamondback orbital atherectomy device (oad) stopped spinning and lost power in the middle of the third treatment pass on medium speed. The saline pump went into standby mode and all led lights on the oad turned off. Despite troubleshooting the issue recurred. The oad was removed, and imaging of the superficial femoral artery (sfa) was performed, which revealed slow flow. Balloon angioplasty of the sfa and common femoral artery was performed. Imaging was again performed and showed slow flow in the sfa, popliteal, and tibial arteries. Imaging also showed emboli in the peroneal and popliteal arteries. The viperwire guide wire was removed. Aggressive balloon angioplasty was performed in both tibial vessels in an attempt to resolve the emboli seen in that area. Imaging of the tibial artery was then performed and revealed complete occlusion of the pt artery. The complete occlusion of the pt artery was likely caused by a flow limiting dissection due to a non-csi device since csi devices were no longer being used in that region. The patient was admitted to the hospital, however no additional intervention was performed and the patient was discharged.
 
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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 Key9757000
MDR Text Key189563289
Report Number3004742232-2020-00053
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/19/2021
Device Model NumberDBP-200SOLID145
Device Catalogue NumberDBP¿200SOLID145
Device Lot Number291882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2021
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: 02/26/2020 Patient Sequence Number: 1
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