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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not 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
A diamondback peripheral orbital atherectomy device (oad) was used via tibial access to treat a chronic total occlusion in the anterior tibial artery (at).Intravascular ultrasound showed luminal placement.The physician planned to work from the at to the tibioperoneal trunk (tpt) and popliteal.Atherectomy was performed on low speed for a distance of about 15cm.A rest period was then observed.Several medium speed treatments were then administered with 25 second rest periods and without any complications.The oad was repositioned closer to the tpt, and a low speed treatment was initiated.The crown advanced about 2cm and continued to orbit, but it could not be advanced any farther.The driveshaft could not be retracted.After some maneuvering, the driveshaft moved, but it became entrapped again.The device was then eventually removed with additional force and was retracted back to the guide catheter.It was determined the vessel had spasmed, thereby causing the maneuvering difficulties.All devices were removed from the patient.Some intimal damage was noted on angiography, but ivus confirmed only minor dissections.Balloon angioplasty was used to treat the damage.The patient was stable following the procedure.

• 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 12852017
• Report Number: 3004742232-2021-00393
• Device Sequence Number: 5094797
• Product Code: MCW
• UDI-Device Identifier: 10850000491240
• UDI-Public: (01)10850000491240(17)230331(10)371751-1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/22/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: 7-10057-08
• Device Lot Number: 371751-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American