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

Model Number	PRD-SC30-125
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Return of the device has been requested.If the device is received, it will be analyzed, and a supplemental report will be submitted with the findings.Csi id: (b)(4).
Event or Problem Description
A stealth orbital atherectomy device (oad) was used for treatment of lesions in the mid superficial femoral artery (sfa) and popliteal arteries via antegrade femoral access.The sheath continually backed out during primary wiring.After the wire was placed, the oad was positioned in the sfa, and one treatment was performed on low speed.The sheath again shifted back, and the oad stopped spinning.The user removed the device and sheath and left the wire in place.The sheath was kinked and was replaced to continue the procedure.It was observed at that time that the crown and nose of the oad were no longer on the driveshaft.Fluoroscopy showed that the crown and nose were still in the sfa on the guide wire.A snare was used to ensure that both the viperwire and oad fragment were safely removed.A new wire and oad were used to complete the procedure as planned with atherectomy and angioplasty.No adverse patient consequences were noted, and no further intervention was needed to complete the procedure.The patient was stable with palpable and doppler pulses.
Additional Manufacturer Narrative
Device analysis conclusion: the oad was received by csi for analysis.Visual examination confirmed the reported fracture.Review of the device data log identified a stall condition, which confirmed the report that the oad stopped spinning.The cause of the stall is unknown.Scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.It is hypothesized that the driveshaft was subjected to a high stress environment such as a kinked location that led to the fatigue and eventual fracture.However, this could not be conclusively confirmed, and the exact root cause of the fracture is 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: 10333.

• 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: 12159953
• Report Number: 3004742232-2021-00258
• Device Sequence Number: 3705510
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)230228(10)367318-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 02/28/2023
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 367318-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: 65 YR