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	03/14/2019
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.Csi id: (b)(4).
Event or Problem Description
Atherectomy was performed with a diamondback coronary orbital atherectomy device and viperwire in the circumflex artery, proximal to distal.Atherectomy was applied in the proximal to mid section of the vessel.Following that, the viperwire was advanced into the obtuse marginal (om) branch since the distal lesion was near the bifurcation of the om.Glideassist was used to advance the oad into the lesion and a reverse spin was applied for treatment.The oad was 10mm away from the first radiopaque marker of the viperwire.The oad was removed and a competitor wire was placed for balloon angioplasty support.Angioplasty was performed.The viperwire was then removed, but the distal tip of the viperwire remained in vivo.Another guide wire was inserted alongside the other competitor wire, and an attempt was made to remove the viperwire tip.While attempting to remove the wire tip, the proximal portion of the wire became buried in the subintimal space.Since the buried wire was in the location where the physician was planning to stent, the tip was left in vivo, and a stent was placed over it.Intravenous ultrasound was used to confirm stent apposition and to visualize the wire.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8505619
• Report Number: 3004742232-2019-00104
• Device Sequence Number: 13933269
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)201031(10)11042801
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup
• Report Date (Section B): 04/11/2019

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: 10/31/2020
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11042801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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: 73 YR