BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 17406821 · Received July 27, 2023

    Report

    Report Number
    9681477-2023-00120
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 2, 2023
    Report Date
    November 14, 2023
    Manufacturer
    CORDIS US CORP.
    Product Code
    DQX
    UDI-DI
    10705032055031
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, PACKING DAMAGE WAS FOUND FOR THE 0.35 EMERALD DIAGNOSTIC GUIDEWIRE (DGW). THE SEAL OF THE INNER PACKAGE WAS OPENED. THE STERILE POUCH RECEIVED WAS OPENED/COMPROMISED. THE LAB NURSE NOTED THIS UNSEALED PACKAGING DURING THE PREPARATION SESSION AND REPLACED IT WITH A NEW EMERALD DGW TO COMPLETE THE PROCEDURE. IT IS NOT KNOWN IT THE NEW GUIDEWIRE USED WAS TAKEN FROM THE SAME MULTIPACK OF THE COMPLAINT DEVICE; HOWEVER, THE OTHER FOUR (4) PRODUCTS FROM THE SAME BOX WERE USED WITHOUT ANY COMPLAINTS. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT IS STORED IN THE STERILE CONSUMABLE ROOM. THE DEVICES ARE STORED ON A SHELF IN THE LAB. ONE VIDEO WAS RECEIVED FOR ANALYSIS, WHICH REVEALED THE BOTTOM SECTION OF THE POUCH WAS NOT SEALED. ONE NON-STERILE GUIDEWIRE ¿DGW .035 FC J3MM 260CM TEF¿ WAS SUBSEQUENTLY RECEIVED FOR ANALYSIS AND DID NOT PRESENT WITH ANY DAMAGES OR ANOMALIES. THE ORIGINAL PACKAGING WAS NOT RETURNED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35265182 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE FAILURE REPORTED BY THE CUSTOMER ¿PACKAGING/POUCH/BOX- COMPROMISED STERILITY-SEAL OPEN¿ WAS CONFIRMED FROM THE VIDEO ANALYSIS. HOWEVER, IT COULD NOT BE CONFIRMED BY PRODUCT EVALUATION BECAUSE THE PACKAGING WAS NOT RETURNED FOR ANALYSIS. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿DO NOT USE IF PACKAGE IS OPEN OR DAMAGED.¿ PER ANALYSIS OF THE RETURNED DEVICE, THE OPEN SEAL WAS FOUND TO BE MANUFACTURING RELATED AND A RISK ASSESSMENT WAS INITIATED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35265182 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT COULD BE ASSOCIATED WITH THE EVENT REPORTED. THE DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, PACKING DAMAGE WAS FOUND FOR THE 0.35 EMERALD DIAGNOSTIC GUIDEWIRE (DGW). THE ACTUAL PRODUCT WAS NOT DAMAGED. THE STERILE POUCH RECEIVED WAS OPENED/COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS FOUND WHEN THE NURSE SENT THE PRODUCT TO THE OPERATING TABLE. THE PRODUCT IS STORED IN THE STERILE CONSUMABLE ROOM. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A VIDEO OF THE EVENT WAS PROVIDED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637941 EMERALD WIRE, GUIDE, CATHETER DQX CORDIS US CORP. 35265182 10705032055031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.