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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A diamondback 360 peripheral orbital atherectomy device (oad) was used for an atherectomy procedure.A perforation was observed.
Additional Manufacturer Narrative
The investigation is ongoing.A final report will be submitted once the investigation is complete.Csi id: (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, d4, d9, g3, g6, h2, h3, h4, h6, h6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vessel perforation is a potential adverse event that may occur and/or require intervention with use of the system.H6: investigation findings code: 4247 - suggested code is biological material present on device.The oad was returned for analysis.Examination of the driveshaft crown section identified adhered biological material.It was unable to be determined whether the adhered biological material was related to the perforation.The morphology and exact root cause of the biological material was unknown.Examiniation of the crown did not reveal any damage or abnormalities that could have led to the perforation.The crown diameter was measured and met specification.The root cause of the perforation was unable to be conclusively determined.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).
Additional Manufacturer Narrative
Updated fields: b4, b5, g2, g3, g6, h2, h6.
Event or Problem Description
Additional information received indicated during the procedure, the oad arrested on the viperwire advance guide wire and was unable to be removed.An advanced technique was used to remove the oad and guide wire.A proximal anterior tibial dissection was observed.Balloon angioplasty was used to treat the dissection, and subsequently complete 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18058259
• Report Number: 3004742232-2023-00270
• Device Sequence Number: 5913847
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)241031(10)458781-1
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2024

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: 10/31/2024
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 458781-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 04/04/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/19/2024; 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male