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

Model Number	DBP-150SOLID200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the conclusion of the failure analysis investigation the audible noise and cessation of spinning events could not be confirmed.However, the deformation and unraveling event were confirmed via analysis.The tip of the oad was missing upon receipt of the device for analysis.Field staff was contacted regarding the missing tip; field staff was not aware the tip was missing and did not have any information about when it became detached.Scanning electron microscopy analysis of the distal end of the drive-shaft identified evidence of having been laser welded, but since the tip bushing was not returned, the quality of the laser weld could not be determined.The unraveled drive-shaft is determined to be due to the oad spinning without an attached tip bushing.The exact cause of the detached tip bushing 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.Csi id: (b)(4).
Event or Problem Description
Shortly after the diamondback peripheral orbital atherectomy device (oad) was turned on, an unexpected audible noise was heard and the device stopped spinning.The device was re-positioned, but the issue recurred.Upon removal from the patient, the tip of the oad was found to be frayed and shredded, and it was wrapped around the viperwire.The procedure was completed using a balloon only at no consequence to the patient.The tip of the oad was not present upon receipt of the oad for analysis.Additional information was requested regarding whether the tip could have been left behind in the patient.The response received was that the tip was not left in situ as confirmed by field staff present at the procedure.

• 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: 7903574
• Report Number: 3004742232-2018-00292
• Device Sequence Number: 13841034
• Product Code: MCW
• UDI-Device Identifier: 10852528005367
• UDI-Public: (01)10852528005367(17)200331(10)220483
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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: 03/31/2020
• Device Model Number: DBP-150SOLID200
• Device Lot Number: 220483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1