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

Model Number	DBP-150CLASS145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.A visual examination identified adhered biological material on the driveshaft distal to the crown.The adhered material prevented a guide wire from passing through the area and the driveshaft was cut proximal to the biological material.The guide wire was able to pass through the remaining device without encountering resistance.The oad was powered on and off multiple times with no issues observed.At the conclusion of the device analysis investigation, the report that the device became stuck in the vessel and a vessel perforation occurred could not be confirmed through analysis.It is possible that the adhered material observed on the driveshaft may have been related to the stuck in vessel and perforation events, however this could not be confirmed.Examination did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation is unknown.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
Orbital atherectomy was selected for treatment of the left anterior tibial (at) and tibioperoneal trunk (tpt) arteries.The proximal at was 70% stenosed and the mid to distal segment was a straight chronic total occlusion (cto).The tpt was 90% stenosed, with the peroneal artery providing collaterals to the posterior tibial artery.Some difficulty was encountered crossing the at lesions and the cto, but there were no unusual turns or bends of the wire and imaging revealed that the microcatheter was intraluminal.Proximal to distal treatment to the at with the diamondback peripheral orbital atherectomy device (oad) was performed.Treatment was continued to the cto on low speed, with some overlapping treatment.Medium speed was selected, the oad sounded as though it had stalled, and the device had become stuck in the vessel.The oad was pulled back through the lesion, and during removal wire access was lost.The oad and wire were both removed and imaging of the cto revealed a vessel perforation.Attempts to re-cross the cto with a catheter and non-csi wire were unsuccessful.Percutaneous transluminal angioplasty was performed to the proximal portion of the at and tpt, following which a residual perforation remained.The leg was wrapped with an elastic bandage to provide external compression.Following the procedure, the patient remained hemodynamically stable and the patient's lower extremity remained warm with a pulse and no signs of swelling.

• 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 12917036
• Report Number: 3004742232-2021-00405
• Device Sequence Number: 5658106
• Product Code: MCW
• UDI-Device Identifier: 10850000491240
• UDI-Public: (01)10850000491240(17)230531(10)381376-1
• 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): 12/02/2021

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: 05/31/2023
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: 7-10057-08
• Device Lot Number: 381376-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White