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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 procedure was planned for a subtotal occlusion in the anterior tibial artery.An attempt was made to cross the lesion with a re-entry device, but the attempt was unsuccessful even after the device was torqued, which likely caused some vessel damage.Two guide wires were abutted from foot and groin access sites.A catheter was used to exchange for a viperwire guide wire.The diamondback peripheral orbital atherectomy device (oad) was activated, but it stalled several times and became stuck in the vessel.The opinion of the physician was that the device was likely subintimal.The physician pulled with force on the oad, and endothelium was observed on the oad.No flow was observed, and unplanned stents were placed in the vessel.At the conclusion of the procedure, the patient was fine and flow in the vessel had been restored.

• 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
• MDR Report Key: 11569903
• Report Number: 3004742232-2021-00086
• Device Sequence Number: 11813662
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)220930(10)344011
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/25/2021

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: 09/30/2022
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 344011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/25/2021
• 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: 60 YR
• Patient Weight: 98