MalfunctionMCW

TURBO-ELITE 1.4MM RX LASER

Received Jun 17, 2025 · Event occurred May 7, 2025

Report MW5171570 · MDR key 22233538

Device

Generic name

Catheter, Peripheral, Atherectomy

Manufacturer

Philips/spectranetics Corp.

Catalog number

414-159

Lot number

FBF23H29A

Product problems

Failure to Calibrate

Patient

82 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

LASER ATHERECTOMY CATHETERS WOULD NOT CALIBRATE X2. THIRD CATHETER OPENED AND CALIBRATED AND ABLE TO BE USED. PHILIPS REP AT BEDSIDE TO TROUBLESHOOT AND HELPED RESOLVE ISSUE. NEITHER CATHETER ENTERED PATIENT BODY. TWO DIFFERENT LOTS: 1. 414-159, LOT 0303349017, EXP 2026-11-22; 2; 414-159, LOT FBF23H29A, EXP 2025-09-13. REFERENCE REPORT: MW5171569.