MalfunctionMCW
TURBO-ELITE
Received Jun 29, 2023 · Event occurred Jun 12, 2023
Report 17224183 · MDR key 17224183
Device
Generic name
Catheter, Peripheral, Atherectomy
Manufacturer
Spectranetics Corp.Model number
410-154Catalog number
410-154
Lot number
FBE22C18A
Product problems
- Calibration Problem
Patient
28105 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE LASER PRODUCT SPECTRANETICS TURBO ELITE 0.9 MM RX LOT #: FBE22C18A, REF #: 410-154, EXP DATE: 04/07/2024, DID NOT CALIBRATE WHEN TESTED DURING THE PROCEDURE.