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

Model Number	PRD-SC30-200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis.The driveshaft tip bushing section was fractured at the distal edge of the crown and also returned.Corrosion was noted on the tip bushing, but there was no damage seen that would have contributed to the corrosion.Scanning electron microscopy of the fractured driveshaft and driveshaft filars identified the presence of fatigue markings.The root cause of the fractured driveshaft was undetermined; however, this type of damage is an indication the device had experienced some form of elevated stresses resulting in the observed fractures.It could be the result of localized, elevated stress levels applied to the driveshaft while spinning.The oad was plugged into an in-house saline pump, and the led's on the handle assembly illuminated and defaulted to the low speed led as expected.The oad speeds were tested and the device spun at all three speeds with no abnormalities observed.At the conclusion of the device analysis investigation, the event of an oad driveshaft fracture was confirmed through analysis.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 a procedure, the tip of the diamondback peripheral orbital atherectomy device (oad) broke off.A 30mm, severely calcified lesion that was 95% stenosed was located in the proximal anterior tibial (at) artery.The vessel diameter was 4.0mm and was not tortuous.The posterior tibial (pt) artery was accessed, and the oad was tracked up the pt and down into the at the lesion site.At the end of the oad treatment it was noted a 30mm portion of the tip of the oad had broken off.The fractured portion remained on the guide wire and was captured with a non-csi catheter from a pedal approach.No device fragments remained in the patient.It was reported that a steep angle was present in the vessel.The patient status was good following the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8473324
• Report Number: 3004742232-2019-00089
• Device Sequence Number: 1474421
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)211031(10)245886
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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
• Report Date (Section B): 04/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 245886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/02/2019
• 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: Required Intervention