InjuryMCW

SPECTRABETUCS TURBO-ELITE ATHERECTOMY CATHETER

Received Jan 27, 2025 · Event occurred Dec 17, 2024

Report MW5165242 · MDR key 21241080

Device

Generic name

Catheter, Peripheral, Atherectomy

Manufacturer

Spectranetics Corp.

Patient

NA · Unknown

Embolism/Embolus
Embolism/Embolus

Narrative

Description of Event or Problem

A PERIPHERAL PROCEDURE COMMENCED, AND A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER USE OF THE TURBO-ELITE, THE LESION WAS THEN TREATED WITH A DRUG-COATED BALLOON. AFTER TREATMENT WITH THE BALLOON, AN EMBOLIZATION OCCURRED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".