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

Model Number	DBP-EX-150SOL145
Medical Device Problem Codes	Contamination (1120); Off-Label Use (1494)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vessel occlusion is a potential adverse event that may occur and/or require intervention with use of the system.H6 results code: 4247 - suggested code is biological material present on device.The oad was returned for analysis.Analysis revealed adhered biological material on the driveshaft at the crown section.Examination did not reveal any damage that would have contributed to the material accumulation.The morphology and exact root cause of the accumulated biological material was unknown.When tested, the oad functioned as intended.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 diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was used to treat the superficial femoral artery (sfa).The lesion was an in-stent chronic total occlusion (cto).A single vessel runoff to the anterior tibial artery (at) was observed prior to treatment.After treatment, no dissections were observed, however, the at appeared to be occluded.When observing the crown, biological debris was noticed.The at was re-opened with a balloon and tissue plasminogen activator was administered.The procedure was completed with no further issues.

• 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: 18067409
• Report Number: 3004742232-2023-00269
• Device Sequence Number: 18040810
• Product Code: MCW
• UDI-Device Identifier: 10852528005831
• UDI-Public: (01)10852528005831(17)250331(10)481211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: DBP-EX-150SOL145
• Device Catalogue Number: 7-10030-03
• Device Lot Number: 481211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: Required Intervention
• Patient Sex: Unknown