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

Model Number	DBP-EX-200SOL145
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned to csi for analysis.Diagnostic review of the oad revealed several stall events.It is unknown if the stall events are related to the major dissection.The root cause of the stall events was unable to be determined.There is some adhered biological material accumulated on the driveshaft crown section, however, further examination did not reveal any damage or abnormalities that would have contributed to the material accumulation.Also, the crown and sheath diameters were measured and met specifications.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.When tested, the oad functioned as intended.The instructions for use warns to not continue treatment if the guide wire or oad becomes sub-intimal.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 exchangeable orbital atherectomy device (oad) was used sub-intimal to treat a heavily calcified superficial femoral artery (sfa).When treatment was performed on medium speed and high speed, the oad stalled three times.No indicator lights were blinking while the device stalled.An angiogram was performed and revealed a severe dissection.The oad was removed.Balloon angioplasty and stent placement were performed to resolve the dissection.The patient was admitted to the hospital for overnight observation.The patient was stable and discharged.

• 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: 15463325
• Report Number: 3004742232-2022-00227
• Device Sequence Number: 12481233
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)240430(10)430297
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/21/2022

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: 04/30/2024
• Device Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 430297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White