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

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/13/2020
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 material inspection report for this guide wire 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.Mdr 3004742232-2020-00030 exists for the oad fracture that occurred during the same procedure.Csi id# (b)(4).
Event or Problem Description
During a procedure, a viperwire was selected for use in a tightly stenosed lesion in the mid-right coronary artery (rca).A couple of atherectomy treatment passes were performed on low speed in the proximal rca.During the first pass through the midsection of the rca in a proximal-to-distal direction, the crown of the orbital atherectomy device (oad) jumped through the lesion and became stuck.Attempts to remove the oad were unsuccessful.The physician tried to advance a non-csi guide wire through the lesion, but it was unable to cross.The oad was then cut at the strain relief, and a guideliner was advanced over the driveshaft in an attempt to loosen the oad; however, this was unsuccessful.The oad was then pulled on with considerable force, and the tip of the wire broke off and remained in the rca.The patient coded and was resuscitated.The patient was intubated and admitted to the icu.The mid-to-distal rca was completely shut down, and the patient was experiencing a controlled myocardial infarction.The patient was assessed for surgery by a surgeon but was turned down due to patient status.As of (b)(6) 2020, there was no long-term care plan for the patient.The site declined to provide additional information on the patient's status.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9682350
• Report Number: 3004742232-2020-00031
• Device Sequence Number: 11551953
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210531(10)11135467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: 05/31/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11135467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/07/2020
• 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: Hospitalization; Life Threatening; Required Intervention