MalfunctionGXH

ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEM

Received Apr 3, 2026 · Event occurred Mar 9, 2026

Report 24775711 · MDR key 24775711

Device

Generic name

Device, Surgical, Cryogenic

Manufacturer

Atricure, Inc.

Model number

CRYOSP

Catalog number

A001447

Lot number

162843

Patient

73 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ATRICURE CRYOPROBE (REF#CRYOSP, LOT162843) BLACK PROTECTIVE COVERING SHEARED INTO PATIENT AFTER BEING INSERTED INTO AN 8MM CANNULA PORT. USUALLY, A 12MM CANNULA PORT IS USED. IT IS BELIEVED THAT SHEARING OF BLACK PROTECTIVE COVERING OCCURRED DUE TO OPERATOR ERROR.