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

Model Number	PRD-SC30-MICRO
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was returned to csi for analysis.Visual examination confirmed the reported driveshaft fracture.The location of the fracture could not be determined due to the severe stretching of the driveshaft.There was no other damage observed with the returned oad.Scanning electron microscopy analysis of the fractured filars shows evidence of ductile torsion which is an indication that the driveshaft was pulled to fracture.Therefore, the driveshaft fractured is considered to be the result of removal attempts by the user.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.Patient age: 70.Age is approximate.(b)(4).
Event or Problem Description
A stealth 360 gen 2 peripheral orbital atherectomy device (oad) was used for treatment of a lesion in the anterior tibial (at) artery.Access was obtained via a contralateral femoral approach.The vessel was 100% occluded from the proximal femoral artery to the ankle joint, approximately 300mm.Fluoroscopy revealed moderate calcium.The lesion was primary wired with a non-csi wire.Following wire exchange, three atherectomy passes were performed in the proximal segment on low and medium speeds.The oad was advanced distally to the mid portion of the at and treatment was performed on low speed.The crown of the oad became entrapped in the vessel.Unsuccessful attempts were made to retrieve the oad, including glideassist and backward movement.The oad was forcefully removed, and the tip of the oad driveshaft fractured in the proximal at on the proximal end of the crown.The fragment was abandoned in vivo and not stented as the vessel was occluded.Angiography revealed no other vessels were compromised due to the fragment.Following the procedure, the patient was stable and was discharged.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• 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: 14219958
• Report Number: 3004742232-2022-00107
• Device Sequence Number: 14506260
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)230630(10)385931-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 385931-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White