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

Model Number	DBP-EX-200CLA145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Event or Problem Description
During removal of the diamondback peripheral exchangeable orbital atherectomy device (oad) following a complex critical limb ischemia procedure, resistance was felt when the device entered the catheter to cross the aorta.The device was pulled, and the tip of the oad fractured.The handle of the oad was removed from the patient and the procedure was continued.When the wire was removed, the oad tip fragment dislodged in the right femoral artery.The fragment was secured to the vessel wall using a stent.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The reported oad was returned to csi for analysis.A visual examination confirmed that the driveshaft was fractured at the distal edge of the crown.Scanning electron microscopy was performed but due to secondary damage could not identify the fractography of the driveshaft fracture faces.It is hypothesized that the driveshaft underwent excessive tensile forces near the crown during removal from the vessel.The fractured filars were extending distally from the crown indicating that the filars were pulled to failure, however the exact root cause of the fracture is undetermined.At the conclusion of the device analysis investigation, the reported fracture was confirmed.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 prior to distribution.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 highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 10749704
• Report Number: 3004742232-2020-00341
• Device Sequence Number: 19630433
• Product Code: MCW
• UDI-Device Identifier: 10850000491028
• UDI-Public: (01)10850000491028(17)220228(10)311256
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: 02/28/2022
• Device Model Number: DBP-EX-200CLA145
• Device Catalogue Number: 7-10031-11
• Device Lot Number: 311256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 68