BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TRANSFORM MCCARTHY MITRAL ANNULOPLASTY RING

    MDR report key: 22523715 · Received July 16, 2025

    Report

    Report Number
    1723241-2025-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 16, 2025
    Manufacturer
    GENESEE BIOMEDICAL, INC.
    Product Code
    KRH
    PMA / PMN Number
    K232599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TRANSFORM RING TF-40 (B)(6) REMAINS IMPLANTED AND THE PHYSICIAN HAS REPORTED NO COMPLICATION OR ADVERSE EFFECTS ON THE PATIENT. TRANSFORM RING TF-38 (B)(6) WAS RETREIVED BY GBI REPRESENTATIVES AND A REPLACEMENT RING WAS SENT TO THE HOSPITAL. GBI CONDUCTED AN INVESTIGATION TO DETERMINE THE POTENTIAL CAUSE OF THE DAMAGE PACKAGING. GBI HAS A VALIDATED SHIPPING PROCESS FOR TRANSFORM RINGS AND THE RINGS WERE SHIPPED IN ACCORDANCE WITH GBI PROCEDURES. THE RECORDS FOR THIS SHIPMENT WERE REVIEWED AND THE PRODUCTS MET REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT HAS NOT BEEN DETERMINED IF THE DAMAGE OCCURRED DURING TRANSIT OR AT THE HOSPITAL. GBI HAS UPDATED THE PACKING SLIP PROVIDED WITH PRODUCT SHIPMENTS TO INCLUDE A STATEMENT FOR CUSTOMERS TO INSPECT ALL PACKAGING AND REPORT DAMAGE TO GBI. THE PRODUCT IFU CURRENTLY ALSO INCLUDES INSTRUCTIONS TO INSPECT PACKAGING PRIOR TO USE TO ENSURE THE PACKAGING IS NOT DAMAGED.

    Description of Event or Problem · 0

    GENESEE BIOMEDICAL INC. (GBI) REPRESENTATIVES PRESENT AT (B)(6) HOSPITAL OF (B)(6) DURING THE IMPLANTATION SURGERY OF TRANSFORM MCCARTHY MITRAL ANNULPLASTY RING (TF-40) SN (B)(6), LOT AR24988 REPORTED THE FOLLOWING TO GBI QUALITY MANAGEMENT: SURGICAL STAFF REMOVED TRANSFORM MCCARTHY MITRAL ANNULPLASTY RING (TF-40) SN (B)(6), LOT AR24988 FROM THE OUTER CARDBOARD BOX AND TYVEK PEEL POUCH PACKAGING AND PLACED THE DEVICE ON TO THE BACK TABLE IN PREPARATION FOR SURGERY. PRIOR TO THE IMPLANTATION OF THE RING, THE SURGEON, DR. PATRICK MCCARTHY, NOTICED HOLDER ARM, A COMPONENT OF THE RING HOLDER, WAS BROKEN AND NOTIFIED THE TWO GBI REPRESENTATIVES OBSERVING THE SURGERY. THE HOLDER IS USED TO AID IN THE RING IMPLANTATION AND THE HOLDER ARM PROVIDES A CUT-OFF POINT FOR REMOVING THE HOLDER FROM THE RING AFTER IMPLANTATION. SINCE THE TRANSFORM ANNULOPLASTY RING WAS INTACT AND UNDAMAGED, THE SURGEON REMOVED THE HOLDER AND IMPLANTED THE RING WITHOUT THE HOLDER. THERE WERE NO DELAYS IN THE SURGERY, COMPLICATIONS, OR FURTHER ISSUES. FOLLOWING THE SURGERY, THE CIRCULATING NURSE FOUND THE DISCARDED PACKAGING IN THE TRASH AND DISCOVERED THAT THE EXTERNAL CARDBOARD BOX HAD BEEN CRUSHED AND THE TWO LAYERS OF TYVEK PEEL POUCH PACKAGING HAD SMALL PUNCTURES FROM THE DAMAGED HOLDER ARMS. THE CIRCULATING NURSE NOTIFIED THE SURGEON AND TWO THE GBI REPRESENTATIVES. THE DAMAGE PACKAGING INDICATES THAT THE CRUSHED BOX DAMAGED THE HOLDER ARM AND COMPROMISED THE PACKAGE STERILITY. THE TYVEK PEEL POUCH PACKAGING PROVIDES THE STERILE BARRIER FOR THE GAMMA IRRADIATED ANNULOPLASTY RING.THE SURGEON DETERMINED TO LEAVE THE RING IMPLANTED AND THAT THE RISK OF INFECTION WAS LOW DUE TO THE PRESCRIBED ANTIBIOTIC REGIMEN FOR THE PATIENT BOTH PRE- AND POST-OPERATION. THE GBI REPRESENTATIVES INITIATED A COMPLAINT INVESTIGATION WITH GBI QUALITY ASSURANCE DEPARTMENT, WHO DETERMINED THAT THE EVENT SHOULD BE REPORTED DUE TO THE COMPROMISED STERILITY OF THE DEVICE. THERE HAVE BEEN NO REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES RELATED TO THE COMPROMISED STERILE BARRIER OF THE IMPLANTED TRANSFORM ANNULOPLASTY RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600856 TRANSFORM MCCARTHY MITRAL ANNULOPLASTY RING ANNULOPLASTY RING KRH GENESEE BIOMEDICAL, INC. TF-40 AR24988

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male