MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 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	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A stealth peripheral orbital atherectomy device (oad) was used for treatment of a lesion in the proximal superficial femoral artery (sfa) via left antegrade approach.After the device was advanced into the proximal sfa, it became difficult to advance.Glideassist was enabled, but the difficulty persisted.Glideassist was disabled, and low speed was activated.The oad did not advance, and it was turned off after two seconds.At that time, it became clear the crown was near the distal end of the guide catheter.An attempt was made to pull the wire and oad back, and at that time it was determined the driveshaft had fractured.The oad was removed from the patient.A diagnostic catheter was altered and used to snare the fragment.The sheath and wire were then removed from the patient.The driveshaft fragment remained inside of catheter upon removal.
Additional Manufacturer Narrative
Device analysis conclusion: the oad was returned to csi for analysis.Visual examination confirmed the reported driveshaft fracture at the distal edge of the crown.The distal driveshaft section was returned engaged over the guidewire.There was no damage observed with the returned guide wire that would have contributed to the fracture.Scanning electron microscopy analysis of the fractured filars show evidence of fatigue, which is an indication that the driveshaft was operated in a high-stress environment.However, 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.(b)(4).

• Brand Name: STEALTH 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 12851648
• Report Number: 3004742232-2021-00390
• Device Sequence Number: 17112267
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)230531(10)381647-1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/22/2021

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: 05/31/2023
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 381647-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White