BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC J3MM 260CM TEF

    MDR report key: 7534858 · Received May 22, 2018

    Report

    Report Number
    1016427-2018-01479
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 11, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. PRIOR TO USE, THE PACKAGE FOR A DGW .035 FC J3 MM 260 CM TEF WAS TORN AND THE PRODUCT WAS HALF OUTSIDE THE PACKAGING. NO OTHER INFORMATION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS. PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED SINCE COMPLAINT LOT IS UNKNOWN. A NON-STERILE DGW .035 FC J3 MM 260 CM TEF WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ORIGINAL PACKAGING OF THE REPORTED PRODUCT WAS NOT RETURNED FOR ANALYSIS. PER VISUAL ANALYSIS A KINKED/BENT CONDITION WAS OBSERVED ON THE DISTAL SECTION OF THE GUIDEWIRE. NO OTHER DAMAGES/ANOMALIES WERE FOUND. THE PRODUCT EVALUATION RESULTS DO NOT SUGGEST THAT THE FAILURE REPORTED BY THE CUSTOMER IS RELATED TO THE MANUFACTURING PROCESS. THE REPORTED ¿PACKAGING/POUCH/BOX- FRAYED/SPLIT/TORN - INNER PACKAGE¿ AND ¿PACKAGING/ POUCH/BOX- COMPROMISED STERILITY - SEAL OPEN¿ WERE NOT CONFIRMED DUE TO THE ORIGINAL PACKAGING NOT BEING RECEIVED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS AS WELL AS THE KINKED/BENT CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. STORAGE AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE KINKED/BENT CONDITION FOUND. PER THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED.¿ NEITHER THE PRODUCT HISTORY RECORD (PHR) NOR THE LIMITED INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENTS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. PRIOR TO USE, THE PACKAGE FOR A DGW .035 FC J3 MM 260 CM TEF WAS TORN AND THE PRODUCT WAS HALF OUTSIDE THE PACKAGING. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED SINCE COMPLAINT LOT IS UNKNOWN. THE EVENTS ¿PACKAGING/POUCH/BOX FRAYED/SPLIT/TORN - INNER PACKAGE¿ AND ¿PACKAGING/POUCH/BOX COMPROMISED STERILITY - SEAL OPEN¿ AS REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. PER THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED.¿ THE LIMITED INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE ACCOUNT RECEIVED A PACKAGE FOR A DGW .035 FC J3 MM 260 CM TEF WHICH WAS ALREADY TORN AND THE PRODUCT WAS HALF OUTSIDE THE PACKAGING. TTHE PRODUCT WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    AS REPORTED, THE ACCOUNT RECEIVED A PACKAGE FOR A DGW .035 FC J3 MM 260 CM TEF WHICH WAS ALREADY TORN AND THE PRODUCT WAS HALF OUTSIDE THE PACKAGING. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375890 DGW .035 FC J3MM 260CM TEF WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening