MalfunctionGAS

CORKNOT COMBO KIT

Received Sep 1, 2016 · Event occurred Aug 15, 2016

Report 5920485 · MDR key 5920485

Device

Generic name

Suture, Nonabsorbable, Synthetic, Polyester

Manufacturer

Lsi Solutions, Inc.

Catalog number

31350

Lot number

407707

Product problems

Defective Component

Patient

69 YR

No Consequences Or Impact To Patient
No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A 2ND MITRAL VALVE IMPLANT WAS NEEDED DUE TO A DEFECTIVE SUTURING DEVICE BEING UTILIZED WITH THE ORIGINAL VALVE CURRENTLY BEING IMPLANTED. PER SCRUB TECHS, DOCTOR EXPLANTING THE 1ST VALVE FOR DISCARD, AND REQUESTING TO OPEN A 2ND VALVE. DEVICE AND RE-LOAD SEQUESTERED IN DEPT. NO PATIENT INJURY.