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

Model Number	DBP-EX-175SOL180
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was used to treat a proximal to distal superficial femoral artery (sfa) at 70-80% stenosis.One treatment was completed at low speed and an additional treatment at medium speed.When high speed was on, the oad stopped spinning.The physician pulled the oad out, however, only half of the device was removed while the viperwire guide wire and crown fragments remained in vivo.A 5mm balloon was used to remove the crown fragment.The guide wire was successfully entrapped.The procedure was abandoned and the patient was stable.
Additional Manufacturer Narrative
The oad was returned with the guide wire to csi for analysis.The driveshaft was confirmed to be fractured 48cm from the tip bushing.No other damage was observed on the device.Further investigation of the device revealed a stall event which confirmed the reported complaint of device stopped spinning.Scanning electron microscope analysis of the fractured filars showed evidence of fatigue which is an indication that the driveshaft was spun in a high stress environment.The total spin time during the procedure was 9.83 minutes with one driveshaft cartridge.The exchangeable oad instructions for use specifies a maximum spin time of 8 minutes per cartridge.It is unknown if the long spin time contributed to the fracture and the root cause of the damage was unable to be 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.Related manufacturer report number: 3004742232-2022-00193.Csi id: (b)(4).

• 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: 15259128
• Report Number: 3004742232-2022-00192
• Device Sequence Number: 17589201
• Product Code: MCW
• UDI-Device Identifier: 10852528005893
• UDI-Public: (01)10852528005893(17)221231(10)361136
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 08/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: DBP-EX-175SOL180
• Device Catalogue Number: 7-10030-09
• Device Lot Number: 361136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2020
• 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: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American