MalfunctionMCW

TURBO-ELITE 1.4MM RX LASER

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

Report MW5171569 · MDR key 22233468

Device

Generic name

Catheter, Peripheral, Atherectomy

Manufacturer

Philips/spectranetics Corp.

Catalog number

414-159

Lot number

0303349017

Product problems

Failure to Calibrate

Patient

82 YR · Female

Insufficient Information
Insufficient Information

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. REF REPORT: MW5171570.