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

Model Number	PRD-SC30-MICRO
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A stealth 360 peripheral orbital atherectomy device (oad) was inserted through a 5fr sheath in the anterior tibial (at) artery in retrograde fashion, advanced proximally to the tibioperoneal trunk (tpt) followed by a u-turn approach back through the peroneal artery (pa).The oad was activated, and treatment was performed in the severely calcified proximal at, tpt, and the pa.The oad stopped.The physician disengaged the advancer knob and released the brake.Glideassist was then activated in an unsuccessful attempt to remove the oad.The oad stopped again.The leds were not illuminated.An attempt to reactivate the oad was made, however the device immediately shut off.The physician then pulled the oad ex vivo.Upon removal of the device from the vessel, it was noticed that the tip bushing had become detached.Fluoroscopic imaging was performed, and revealed no evidence of the tip bushing in vivo.Balloon angioplasty was performed followed by imaging to complete the procedure.The patient experienced no consequences as a result of this event.
Additional Manufacturer Narrative
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 orbital atherectomy device (oad) was returned to csi for evaluation.Analysis revealed a driveshaft fracture located at the tip bushing.Evaluation of the data log confirmed a stall event.Scanning electron microscopic (sem) analysis of the fractured filar faces revealed evidence of fatigue.This is an indication that the driveshaft was spun in a high stress environment such as a tight calcified lesion and/or a tight bend that the tip bushing was unable to traverse.However, the root cause of the fatigue could not be conclusively determined.When tested, the oad functioned as intended.Csi id: (b)(4).

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 16513826
• Report Number: 3004742232-2023-00059
• Device Sequence Number: 6296797
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)230831(10)391850-1
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 08/31/2023
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 391850-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic