InjuryMCW
STEALTH
Received Jul 1, 2026 · Event occurred Jun 4, 2026
Report 3004742232-2026-00165 · MDR key 25683629
Device
Generic name
Catheter, Peripheral, Atherectomy
Manufacturer
Cardiovascular Systems IncorporatedModel number
PRD-SC30-150Catalog number
7-10059-03
Lot number
606398-1
Product problems
- Entrapment of Device
- Deformation Due to Compressive Stress
Patient
NA · Unknown
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE ESTIMATED EVENT DATE IS 06/04/2026. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT TWO STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICES BECAME STUCK IN VESSEL AND ONE WAS OBSERVED TO BE BENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE.