InjuryMCW

AURYON ATHERECTOMY CATHETER

Received Jul 2, 2026 · Event occurred Jun 3, 2026

Report 1319211-2026-10029 · MDR key 25689559

Device

Generic name

Auryon Atherectomy Catheter 1.5mm - Hydrophilic Coated

Manufacturer

Eximo Medical Ltd.

Model number

EXM-4001-H000

Lot number

00121952

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

73 YR · Female

Bacterial Infection

Narrative

Description of Event or Problem

SUSPECTED SKIN/SOFT TISSUE INFECTION OF LEFT FOOT WOUNDS TREATED EMPIRICALLY WITH IV ANTIBIOTICS DURING HOSPITALIZATION.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).