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

Model Number	DBP-EX-HANDLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.(b)(4).
Event or Problem Description
During a procedure, a diamondback exchangeable orbital atherectomy device (oad) handle was used to treat an 8-10 centimeter long lesion in the left mid-anterior tibial (at) artery.Two cartridges were used with the oad handle.During the procedure, the at shut down due to potential embolization, and blood flow was limited.However, an embolization was not conclusively confirmed.It was noted that no malfunction with the devices were noted, and the cause of the potential embolization and no flow was not determined.The patient was held in the hospital overnight for evaluation and potential medication therapy.
Event or Problem Description
The patient was hospitalized for a couple days, and blood flow had been restored to some degree, but no additional intervention was performed.It was noted that the patient had been very sick prior to the procedure.No additional patient outcome information was available as the patient was transferred out of the physician's care.
Additional Manufacturer Narrative
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)(6).

• 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
• MDR Report Key: 9727160
• Report Number: 3004742232-2020-00044
• Device Sequence Number: 2475133
• Product Code: MCW
• UDI-Device Identifier: 10850000491035
• UDI-Public: (01)10850000491035(17)210731(10)283010
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/02/2020

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: 07/31/2021
• Device Model Number: DBP-EX-HANDLE
• Device Catalogue Number: 7-10032-01
• Device Lot Number: 283010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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: Hospitalization
• Patient Age: 77 YR
• Patient Weight: 104