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

Model Number	DBP-CART-125SOL200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
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.Csi id# (b)(4).
Event or Problem Description
A diamondback exchangeable orbital atherectomy device (oad) was selected for treatment of the peroneal artery and tibioperoneal trunk.The oad was being positioned using glideassist mode.The guide wire was released while the oad was being advanced, and the oad became stuck in a collateral vessel.Attempts were performed with multiple techniques to pull the oad back, but none were successful.The peroneal artery was open with palpable pulses.The patient was transferred in stable condition to the operating room for removal.The site declined to provide surgery details.On (b)(6) 2020, the patient returned, and the anterior tibial and posterior tibial arteries were opened.Imaging did not show any sign of a csi device in the patient, so the removal surgery was assumed to be successful.

• 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: 10730379
• Report Number: 3004742232-2020-00333
• Device Sequence Number: 14315323
• Product Code: MCW
• UDI-Device Identifier: 10852528005985
• UDI-Public: (01)10852528005985(17)220630(10)330130
• 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): 10/23/2020

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: 06/30/2022
• Device Model Number: DBP-CART-125SOL200
• Device Catalogue Number: 7-10031-07
• Device Lot Number: 330130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: 72 YR