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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2021
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.(b)(4).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was used for treatment of the distal posterior tibial artery (pt) and proximal pedal arch.Intravenous ultrasound showed calcium proximal to the chronic total occlusion (cto).Atherectomy was performed on the distal segment of the pt.However, the oad stopped spinning when it was advanced to the cto segment.Several attempts to reactivate the device were made, but it would not spin and appeared to be entrapped.The physician administered 1000mcg of nitroglycerin to relieve any spasm.Nitroglycerin did not help to free the oad.Multiple unsuccessful attempts were used to manually remove the oad, but ultimately the patient was sent to surgery for removal in stable condition.The patient experienced pain during removal attempts and received multiple doses of versed and fentanyl.

• 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
• MDR Report Key: 12229453
• Report Number: 3004742232-2021-00265
• Device Sequence Number: 1494560
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)230228(10)370006-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 02/28/2023
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 370006-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/27/2021
• 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: 55 YR
• Patient Weight: 68