Stealth
Received Jul 30, 2026 · Event occurred Jul 7, 2026
Report 3004742232-2026-00187 · MDR key 50090293
Device
Generic name
Catheter, Peripheral, Atherectomy
Manufacturer
Cardiovascular Systems IncorporatedModel number
PRD-SC30-125Catalog number
7-10059-02
Lot number
604939-1
Product problems
- Entrapment of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the procedure was to treat mildly calcified, mildly tortuous lesion in anterior tibial artery (AT) through common femoral artery access. The vessel diameter was unknown as no intravascular ultrasound (IVUS) was used. During treatment, the crown of the 1.25 solid Stealth 360 Peripheral Orbital Atherectomy Device (OAD) became stuck at the midpoint of the artery. Additional nitroglycerin beyond standard of care was administered, the OAD was turned off/on several times, and the OAD was removed from the patient. The OAD was intact and had no tissue/plaque. The procedure was completed without using other devices. There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time. Results and conclusions will be provided in the final report.