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	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported by the user facility under medwatch number: (b)(4).Csi staff was aware of the procedure (b)(6) 2019, but notification was inadvertently not provided to the postmarket surveillance department until after the medwatch was received from fda.We apologize for the late filing of this report and have reviewed complaint reporting processes with the responsible party.The results of the investigation are inconclusive since the reported device was discarded by medical staff and was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Based on the information received by csi, the oad was operated in close proximity to the spring tip of the viperwire.The diamondback 360 coronary orbital atherectomy system instructions for use manual states, "do not come within 5 mm of the proximal end of the viperwire guide wire spring tip with the distal end of the oad drive shaft.If the distance between the shaft tip and the viperwire guide wire spring tip is insufficient, the shaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip." 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
During the procedure, a 24mm segment of the viperwire guide wire fractured in a mildly-to-severely tortuous distal circumflex vessel after the oad came too close to the spring tip.The fragment was left in vivo, but a plan was made to attempt retrieval in the future.The patient later expired, and the opinion of the physician is that the death was unrelated to a csi device since the vessel exhibited good flow after tip detachment, and no dissection or perforation was observed.

• 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: 8926816
• Report Number: 3004742232-2019-00222
• Device Sequence Number: 242696
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)200531(10)11028349
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11028349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 08/23/2019
• 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: Other
• Patient Age: 68 YR
• Patient Weight: 102