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

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
The diamondback peripheral orbital atherectomy device (oad) stopped spinning and became stuck in a lesion in the iliac artery following two attempts to spin the oad into the lesion.The vessel was 95% stenotic and the lesion was highly calcified.The oad was eventually removed, and the driveshaft was found to be dislodged near the crown.The catheter was advanced over the oad and wire, and all components were removed.The vessel was then re-wired and stent deployed.There were no adverse effects to the patient.
Additional Manufacturer Narrative
Failure analysis conclusion: the orobital atherectomy device (oad) was receievd with a competitor sheath engaged over the driveshaft and saline sheath.Analysis of the driveshaft section revealed two filars to be fractured at the proximal edge of the crown.Scanning electron microscopy (sem) analysis of the fractured driveshaft filars identified presence of fatigue.Although the root cause of the fractured driveshaft filars is undetermined, it is hypothesized that the crown was spun around a tight bend and/or was advanced into a tight location with enough force to result in buckling of the driveshaft.This could create an elevated stress and fatigue environment and surpass the limits of the oad driveshaft design with potential result of fracture.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8475986
• Report Number: 3004742232-2019-00096
• Device Sequence Number: 13856122
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)210131(10)254329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• 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,Followup
• Report Date (Section B): 04/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 254329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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: Required Intervention