MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-200SOLID145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Embolism (1829); Vascular System (Circulation), Impaired (2572)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9757000
• Report Number: 3004742232-2020-00053
• Device Sequence Number: 2184959
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)211031(10)291882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 291882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR