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	Foreign Body In Patient (2687)
Date of Event	10/01/2019
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.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.(b)(4).
Event or Problem Description
It was reported to csi via medwatch mw5090736 that during a peripheral procedure, the target lesion was located in the tibioperoneal trunk.During treatment, the spring tip of the viperwire guide wire broke off.The guide wire fragment was removed with the use of a snare, and no fragments remained in the patient.It was reported that no injury was sustained by the patient.
Additional Manufacturer Narrative
The diamondback 360® coronary orbital atherectomy system instructions for use manual warns, "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.Use fluoroscopy to monitor movement of the shaft tip in relation to the viperwire guide wire spring tip." csi id# (b)(4).
Event or Problem Description
It was reported to csi via medwatch mw5090736 that a csi orbital atherectomy device (oad) and viperwire guide wire were used to treat two severely calcified target lesion located in the right coronary artery (rca) and the bifurcation of the posterior descending artery (pda).During treatment, the lesion in the rca was successfully treated.Subsequently, the lesion in the pda was treated with multiple treatment passes.The oad came too close to the tip of the guide wire, and the spring tip of the guide wire broke off.The approximately 5 millimeter guide wire fragment was removed with the use of a snare, and no fragments remained in the patient.The procedure was completed with balloon angioplasty and stent placement.It was reported that no injury was sustained by the patient.The opinion of the physician was that the fractured was caused by user error.Re-training of site staff was performed for re-adjusting the wire when glideassist mode was utilized during a procedure and regarding keeping the safe, recommended distance between the guide wire spring tip and oad tip bushing.

• 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: 9443488
• Report Number: 3004742232-2019-00320
• Device Sequence Number: 11317596
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210430(10)11100502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 04/30/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11100502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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