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

Model Number	DBP-200MAX145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned to csi.No damage or abnormalities were observed that could have contributed to the reported event.Diagnostic analysis did not identify any events that could have contributed to the reported event.During analysis, 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.H6 health effect - clinical code 4581: slow/no flow.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that embolization and slow flow are a potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat two lesions in the superficial femoral artery (sfa) with one low speed treatment and one high speed treatment.A lesion in the popliteal artery (pa) was treated with one low speed treatment.A non-csi balloon was used to complete treatment in the sfa and pa.Post treatment, angiographic imaging revealed slow flow through the sfa and pa.The physician suspected embolization of the anterior tibial artery and posterior tibial artery.Intra-arterial nitroglycerin (ntg) was administered; however, embolization was suspected to still be unresolved.Heparin was administered.Percutaneous transluminal angioplasty (pta) with a non-csi balloon was used to treat the at and pt.Additional ntg was administered, and flow was improved.A stent was placed in the tpt.The patient was transferred to post procedure care for recovery.The patient was in stable condition.

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16989184
• Report Number: 3004742232-2023-00152
• Device Sequence Number: 6693760
• Product Code: MCW
• UDI-Device Identifier: 10850026568445
• UDI-Public: (01)10850026568445(17)240831(10)447067-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: DBP-200MAX145
• Device Catalogue Number: 7-10057-10
• Device Lot Number: 447067-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic