MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	RAD-SC30-175
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Variance permits numbering sequence to deviate from the definition of a manufacturer report number found in 21 cfr part 803.3 (m)(3), to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported a stealth 360 peripheral orbital atherectomy device was used to treat a heavily calcified, 90% stenosed popliteal artery.During the procedure, the oad crown became stuck in the small branch of the popliteal artery.It was indicated the vessel was too small for the oad crown, which led to the oad crown becoming stuck.The physician changed access from the left radial to the right femoral.Nitroglycerin and verapamil were administered, followed by balloon angioplasty to complete the procedure.It was indicated tissue was observed on the device ex-vivo.The patient was in stable condition.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B5: event description updated.D9: device return date added.H6: code 1562 added.
Event or Problem Description
It was reported a stealth 360 peripheral orbital atherectomy device was used to treat a heavily calcified, 90% stenosed popliteal artery.During the procedure, the oad crown became stuck in the small branch of the popliteal artery.It was indicated the vessel was too small for the oad crown, which led to the oad crown becoming stuck.The physician changed access from the left radial to the right femoral.Nitroglycerin and verapamil were administered, followed by balloon angioplasty to complete the procedure.It was indicated tissue was observed on the device ex-vivo.The patient was in stable condition.Additional information was received indicating the oad crown detached.No components were left in-vivo.
Additional Manufacturer Narrative
A visual inspection, functional testing, and dimensional analysis were performed on the returned device.The reported material separation, and device contaminated at the user facility are confirmed.However, the device embedded in tissue or plaque and entrapment of device were not able to be confirmed due to the operational context of the reported issues.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported material separation, and device contaminated at the user facility, device embedded in tissue or plaque and entrapment of device appears to be related to use inconsistent with the instructions for use.Analysis of the device identified biological material on the driveshaft crown section, with the crown bond separated.Additional analysis found that that the device had stalled 25 times during the procedure.In this case it is likely that the reported issues are related to use of the oad in a vessel too small for the crown, which his consistent with the complaint details.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported a stealth 360 peripheral orbital atherectomy device was used to treat a heavily calcified, 90% stenosed popliteal artery.During the procedure, the oad crown became stuck in the small branch of the popliteal artery.It was indicated the vessel was too small for the oad crown, which led to the oad crown becoming stuck.The physician changed access from the left radial to the right femoral.Nitroglycerin and verapamil were administered, followed by balloon angioplasty to complete the procedure.It was indicated tissue was observed on the device ex-vivo.The patient was in stable condition.Additional information was received indicating the oad crown detached.No components were left in-vivo.

• Brand Name: STEALTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 20696536
• Report Number: 3004742232-2024-01003
• Device Sequence Number: 14415648
• Product Code: MCW
• UDI-Device Identifier: 10850000491325
• UDI-Public: (01)10850000491325(17)260131(10)524953-1
• Combination Product (Y/N): N
• PMA/510(K) Number: K220568
• Exemption Number: GEN2400518
• 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,Followup,Followup
• Report Date (Section B): 01/16/2025

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: 01/31/2026
• Device Model Number: RAD-SC30-175
• Device Catalogue Number: RAD-SC30-175
• Device Lot Number: 524953-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 01/15/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/27/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White