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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis with the guidewire not engaged.Visual examination confirmed the driveshaft fracture at the distal edge of the crown.The fractured distal section was not returned for analysis, which is consistent with the details reported to csi.The reported bend in the driveshaft was also confirmed.There was no damage observed with the handle assembly.The control knob was traversed distally and proximally while maintaining a 1:1 ratio with the driveshaft crown.The device components were manually examined to determine if there were any functional concerns that may have contributed to the reported events.Scanning electron microscope (sem) analysis identified fatigue striations at the site of the driveshaft fracture.The exact root cause of this reported complaint is undetermined.The oad functioned as intended during testing.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).The report of guidewire fracture will be submitted in mdr 3004742232-2022-00100.
Event or Problem Description
A diamondback gen 2 peripheral orbital atherectomy device (oad) was used for treatment of a lesion in the peroneal artery.The 3.5mm vessel was 90% stenosed, with calcification.The oad buckled near the distal end of the crown after one-to-one motion was lost.Imaging indicated the nose of the oad had separated from the crown.Further imaging confirmed the nose of the oad and a portion of the guidewire had fractured.The oad and wire were removed from the patient.Attempts to retrieve the oad nose and wire fragment were made.The nose of the oad was covered with placement of a covered stent.Peroneal access was obtained, and the physician was able to snare the wire fragment and remove it from the patient.The patient remained in stable condition throughout the procedure.However, the patient's lower extremity had become swollen, and high pressures were noted.The patient required a fasciotomy.Following the fasciotomy, the patient was stable and awaiting discharge.In the opinion of the physician, the specific cause of the adverse event was device entrapment and prolonged sheath placement.

• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 14189472
• Report Number: 3004742232-2022-00099
• Device Sequence Number: 4406637
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)230831(10)396512-1
• 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): 04/22/2022

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: 08/31/2023
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 396512-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White