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

Model Number	RAD-SC30-175
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.Visual examination of the device did not reveal any damage.A guide wire was inserted through the driveshaft and handle assembly without resistance.Power was applied to the device and all led lights were visibly lit, with the oad defaulting to low speed as expected.The oad was powered on and off several times without any issues observed.A saline solution was poured over the motor assembly and cable set, and the oad continued to spin and function as intended.The start switch, and brake assembly were examined and there was no damage or abnormalities observed.At the conclusion of the device analysis investigation, the reports that the oad sounded as though it were increasing in speed and would not stop spinning were not 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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
During a procedure, the stealth orbital atherectomy device (oad) was operated on medium speed for one treatment pass.The oad was switched to high speed and sounded very loud as though it were increasing in speed.An attempt was made to turn off the oad using the power button, but it was unsuccessful, and the oad continued spinning.The saline pump was powered off, in order to cease power to the oad.The oad was removed from the sheath and the pump was powered back on.This caused the oad to power back up, and the same issue recurred.The device was replaced with a second oad to complete the procedure.There were no patient complications.

• 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 55112
• MDR Report Key: 9380427
• Report Number: 3004742232-2019-00308
• Device Sequence Number: 479913
• Product Code: MCW
• UDI-Device Identifier: 10852528005770
• UDI-Public: (01)10852528005770(17)210331(10)265106
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/26/2019

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: 03/31/2021
• Device Model Number: RAD-SC30-175
• Device Catalogue Number: 7-10058-03
• Device Lot Number: 265106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1