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

Model Number	PRD-SC30-200
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis along with a viperwire guide wire and non-csi catheter.A visual examination was performed and found that the oad saline sheath was separated and the driveshaft was fractured.The fractured distal section of the driveshaft was not returned with the device.The guide wire was observed to be kinked and the non-csi catheter was damaged at the distal end.Scanning electron microscopy was performed and identified the presence of fatigue on the fractured filar surfaces, which indicates that the fracture occurred while the device was spinning.The saline sheath and driveshaft damage likely resulted from elevated localized stress levels applied while the device was spinning.It is hypothesized that this damage occurred as a result of the damage observed at the distal end of the returned catheter, however this could not be confirmed and the root cause of the damage is unknown.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.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the crown of the device became detached.During treatment of a lesion in the distal superficial femoral artery (sfa), multiple passes were performed with the oad around a tight arch and the device stopped spinning.Upon removal, the oad became stuck in a non-csi sheath and a portion of the device became detached.The oad was replaced and a larger sheath was used to complete the procedure with no patient complications.It was confirmed that no portion of the oad remained in the patient, and no intervention was required to remove the device fragment from the body.Per the physician, the cause of this event was the high tortuosity of the vessel and the calcium present.

• 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; st. paul MN 55112
• MDR Report Key: 8587538
• Report Number: 3004742232-2019-00132
• Device Sequence Number: 13869785
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)220131(10)254138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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): 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 254138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR