MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 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	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis conclusion: the oad and wire were received at csi for analysis.Visual examination confirmed a driveshaft fracture at the proximal edge of the crown.The driveshaft fragment remained engaged on the guide wire.There was no other damage noted.The oad functioned as intended during functional testing.Driveshaft flexing at the weld location can initiate a fatigue failure, and scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft 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 the fracture is 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." at the conclusion of the device analysis investigation, the reported stall could not be confirmed.However, the reported driveshaft fracture was confirmed.(b)(4).
Event or Problem Description
Following approximately five treatments on low speed in the mid right coronary artery (rca), the oad was advanced proximal to the next area of intended treatment.Before the physician could press the on/off button, the oad pitch changed, and the oad stalled.The distal driveshaft and crown then appeared to be detached from the device on imaging.The oad was removed from the patient.The oad fragment was snared, and a stent was placed to complete the procedure.

• Brand Name: DIAMONDBACK 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: 11332190
• Report Number: 3004742232-2021-00044
• Device Sequence Number: 13711795
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211130(10)297139
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 02/16/2021

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: 11/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 297139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• 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: 74 YR