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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination did not reveal any damage.The device was turned on and off numerous times with no issues observed.While performing function testing, the motor cable set, start switch and potted pcb were soaked with saline solution and the power button was activated with no unintended spinning observed.The oad was turned off and rested without the oad turning back on.There were no visible leak paths, and no damage to the start switch cables or the cable retainer.Further examination revealed there was no damage to the motor, cable set, brake or speed switch ribbons and no damage observed that would have contributed to the reported event.At the conclusion of the device analysis, the reported event that the oad spun independently without being prompted could not be confirmed as the oad functioned as intended during analysis.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
The peripheral diamondback orbital atherectomy device (oad) spun independently without being prompted.During testing outside of the body, the oad intermittently started and stopped spinning and the saline infusion pump was used to troubleshoot the issue.After 2 to 3 seconds the oad spun without being prompted at 60,000 rpms for approximately 2 to 3 seconds before becoming caught on sterile towels in the field.The device was replaced with a second oad to complete the procedure with no major delays.The patient was discharged without any 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: 9197898
• Report Number: 3004742232-2019-00269
• Device Sequence Number: 19619678
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210731(10)281367
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/16/2019

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: 07/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 281367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 52