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

Model Number	DBP-150CLASS145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned with a non-csi wire engaged in the fractured driveshaft section.A cut was also observed in the driveshaft/saline sheath near the handle.Additional damage and stretching to the driveshaft and saline sheath were observed.This damage was likely the result from troubleshooting and removal efforts of the oad during the procedure.Scanning electron microscopy (sem) analysis of the driveshaft fracture showed evidence of cut filars and tensile failure on the distal fracture.It is possible the driveshaft fractured due to tensile forces occurring during removal attempts by the physician.Review of the device data log identified stall events followed by several start switch presses, which did not start the oad due to a stall lockout.It was unable to be determined it the stall events were related to the reported event.The cause of the events was unable to be conclusively 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.Csi id: (b)(4).
Event or Problem Description
The diamondback 360 peripheral orbital atherectomy device (oad) crown became stuck in the anterior tibial artery (at) during treatment.The physician was unable to remove the oad.The oad driveshaft and crown fractured, and approximately 2 centimeters of the driveshaft remained in the at.Prior to the procedure, the at was completely occluded and therefore the physician did not have concerns that the at would remain occluded, without impact to flow.The physician placed a stent in the superficial femoral artery down to the peroneal artery.The procedure was complete without further complications.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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16818347
• Report Number: 3004742232-2023-00119
• Device Sequence Number: 12536671
• Product Code: MCW
• UDI-Device Identifier: 10850000491240
• UDI-Public: (01)10850000491240(17)250131(10)472237-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: 7-10057-08
• Device Lot Number: 472237-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 68 KG