MalfunctionLIT

PASSEO-18 2.5/150/130

Received Jul 10, 2026 · Event occurred Jun 18, 2026

Report 8043892-2026-06255 · MDR key 25775565

Device

Generic name

Peripheral Dilatation Catheter

Manufacturer

Biotronik Ag

Model number

366130

Lot number

10255299

Product problems

Fracture

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MILDLY TORTUOUS SECTION OF THE TIBIAL ARTERY. THE BALLOON DETACHED FROM THE CATHETER DURING THE PROCEDURE AND WAS REMOVED FROM THE PATIENT USING A SNARE.