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	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
During a procedure, the spring tip of the coronary viperwire guide wire detached.The 80% stenosed target lesion was located in the left anterior descending coronary artery (lad), in an area of the vessel that was 3mm in diameter.Three treatment passes were performed with the csi orbital atherectomy device (oad).It was noted that the tip bushing of the oad did not come near the spring tip of the guide wire during treatment.The viperwire guide wire separated when the wire was being removed from the patient.The fragment passed through the aorta and down into the iliac artery in the leg.The fragment was retrieved via snare, and the procedure was completed.The patient was fine following the procedure.
Additional Manufacturer Narrative
The reported guide wire was received for analysis.The guide wire was fractured at the spring tip core wire, and the fractured segment was returned.Scanning electron microscopy of the fracture faces revealed the guide wire fractured due to fatigue.No galling or deformation was observed on the guide wire.It was hypothesized that the spinning driveshaft was advanced to the point of making contact with the spring tip section causing a high stress environment and resulting in a fatigue fracture.The root cause was considered user error by spinning too close to the guide wire spring tip.The oas instructions for use 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.Use fluoroscopy to monitor movement of the shaft tip in relation to the viperwire guide wire spring tip." at the conclusion of the device analysis, the reported event of a guide wire fracture was confirmed.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.Csi id# (b)(4).

• 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
• MDR Report Key: 10233770
• Report Number: 3004742232-2020-00187
• Device Sequence Number: 3195187
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210630(10)11163999
• Combination Product (Y/N): N
• 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): 07/17/2020

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: 06/30/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11163999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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: 55 YR