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

Model Number	PRD-SC30-200
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis.The guide wire was received engaged in the oad.It was observed that the oad driveshaft was fractured distally adjacent to the lap weld but the crown and driveshaft tip bushing were intact and undamaged.Scanning electron microscopy showed evidence of torsional fracture and fatigue.This type of damage typically indicates the fracture occurred while the oad was spinning.There was no issue identified with the laser weld of the oad.There was no additional damage noted on the oad.The oad motor speeds were tested and the device spun during all three speeds with the led's illuminating individually at each speed setting as expected with no abnormalities observed.A kink was observed in the returned guide wire that coincided with a bend in the oad driveshaft, however, when the guide wire was removed, the bend in the driveshaft was no longer visible.There was no additional damaged observed on the guide wire.At the conclusion of device analysis, the event of an oad crown fracture was not confirmed.The event of the oad being stuck in the lesion was unable to be conclusively confirmed.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.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).
Event or Problem Description
During a procedure, the crown on the stealth peripheral orbital atherectomy device (oad) broke off.The target lesion was a 15 cm long, diffusely calcified and 90% stenosed lesion located in the 6mm, tortuous common femoral artery.During the second treatment, the oad became stuck in the lesion.The physician pulled and torqued the oad in an attempt to remove the oad, and the crown of the driveshaft broke off.It was noted that the device fragment was snared, and no part of the device was left in the patient.The procedure was completed with balloon angioplasty, and the patient was discharged the same day of the procedure.Device analysis identified the fracture occurred at the lap weld, not the crown.It was confirmed the correct device was returned for analysis.

• 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: 8491072
• Report Number: 3004742232-2019-00099
• Device Sequence Number: 19278573
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)211130(10)247397
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/08/2019

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: 11/30/2021
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 247397
• 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: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• 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