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

Model Number	PRD-SC30-125
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stealth 360 peripheral orbital atherectomy device (oad) was received at csi for analysis with the guide wire engaged.The guide wire spring tip was protruding out of the driveshaft, the driveshaft was stretched and damaged and a kink was observed in the driveshaft.These damages are consistent with the reported complaint indicating that force was used to remove the oad and guide wire.There was no damage to the driveshaft crown section.When tested, the oad functioned as intended and no device abnormalities were identified that could have contributed to the reported vessel spasm.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).Csi id: (b)(4).
Event or Problem Description
Atherectomy was being performed in the superficial femoral artery (sfa) and posterior tibial (pt) artery in an antegrade movement beginning in the sfa.When the stealth 360 peripheral orbital atherectomy device (oad) was advanced to the segment of the pt near the medial malleolus the crown became stuck.The oad stalled.Intraarterial nitroglycerine was administered and an unsuccessful attempt was made to remove the oad.A blood pressure cuff with occlusive pressure was placed around the calf for approximately five minutes.When the blood pressure cuff was removed, and with significant force, the oad and guide wire were pulled out together as the guide wire had become kinked.Balloon angioplasty was then performed to complete the procedure.Following the procedure, the patient was in satisfactory condition.In the opinion of the physician, the cause of the event was due to a vessel spasm.

• 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: 14952709
• Report Number: 3004742232-2022-00163
• Device Sequence Number: 20559179
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)240228(10)422088-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/07/2022

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: 02/28/2024
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 422088-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: Black Or African American