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

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis conclusion: the oad was received at csi for analysis.Visual examination confirmed the driveshaft fracture on the proximal edge of the driveshaft crown.Driveshaft flexing at the weld location can initiate a fatigue failure, and scanning electron microscopy analysis identified fatigue striations at the site of the fracture.It is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.However, the exact root cause of fracture remains undetermined.The diamondback 360® coronary orbital atherectomy system instructions for use manual warns, "never force the crown if any resistance is felt within the vessel as vessel perforation may occur.If resistance is felt, retract the crown, while monitoring the cause of the resistance, and immediately stop treatment.Use fluoroscopy to analyze the situation and to monitor the cause of the resistance.".
Event or Problem Description
A diamondback gen 2 coronary atherectomy device (oad) was used for treatment of lesion in the left anterior descending artery (lad) and right coronary artery (rca) via right radial access.The calcified, mid-lad lesion was accessed with a non-csi guide catheter and was crossed with a non-csi microcatheter and guide wire.Following exchange to viperwire, the microcatheter and non-csi wire were removed.The oad was successfully tested ex vivo and advanced to the target lesion.Glideassist was used to advance the crown proximal to the mid-lad lesion.Three treatments were performed on low speed, each ranging from 17 to 20 seconds with 40 seconds of rest between.However, the oad could not be advanced through the lesion.Glideassist was enabled, and the oad crown was advanced distal to the lesion without issue.Four low-speed treatments were performed ranging from 16 to 18 seconds each with 40 second rest times between.Imaging thereafter showed that the crown and nose of the oad driveshaft were proximal to the lesion, but the remainder of the driveshaft was in the proximal lad; the oad had fractured proximal to the crown.Fluoroscopy showed no vessel complications, and the patient was stable without hemodynamic changes.The oad was removed, and the viperwire was pulled in attempts to remove the oad fragment.During the first attempt, the wire was moving freely, but the fragment did not move.On the second attempt, the fragment and wire were successfully removed together.Additional imaging showed no vessel damage.The procedure was completed with angioplasty and stent placement.

• 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: 12181895
• Report Number: 3004742232-2021-00264
• Device Sequence Number: 936581
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230131(10)365466-1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 365466-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 130