MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 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	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis conclusion: the oad was received at csi for analysis.Visual examination confirmed the reported driveshaft fracture on the distal edge of the crown.Scanning electron microscopy analysis identified fatigue striations at the site of the fracture.It is hypothesized that this driveshaft underwent extreme flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.However, this could not be confirmed, and the exact root cause of the fracture remains undetermined.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
The stealth peripheral orbital atherectomy device (oad) could not be advanced over the iliac bifurcation.The bifurcation had a narrow diameter and was heavily calcified.Following several attempts (pulling back then advancing), the sheath of the oad was able to pass the bifurcation.The oad was then advanced to the treatment area at the ostial superficial femoral artery.The device was advanced farther following treatments on low, medium, and high speeds, and the nose of the driveshaft appeared fractured on imaging.The oad was removed.The nose remained on the wire and was retrieved with the aid of a snare.The procedure was completed with angioplasty.

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 12133859
• Report Number: 3004742232-2021-00248
• Device Sequence Number: 14485962
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)230131(10)362060-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 07/08/2021

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: 01/31/2023
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 362060-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/08/2021
• 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: 76 YR
• Patient Weight: 84