BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 5F INFINITI TL JR4.0 100C

    MDR report key: 3811463 · Received May 15, 2014

    Report

    Report Number
    9616099-2014-00327
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 21, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING PREPARATION OF A 5F INFINITI DIAGNOSTIC CATHETER, IT WAS REPORTED, THAT LEAKAGE WAS FOUND. IT IS UNKNOWN FROM WHERE IN THE DEVICE THE LEAKAGE ORIGINATED. THE PRODUCT WAS EXCHANGED FOR ANOTHER SAME LIKE PRODUCT. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THE INTENDED PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT RESTERILIZED AND WAS PREPPED ACCORDING TO THE IFU. A NON STERILE CATH F5 INF JR 4 100CM DIAGNOSTIC CATHETER WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, NO ANOMALIES WERE FOUND. A LAB SAMPLE SYRINGE FILLED WITH WATER WAS ATTACHED TO THE HUB OF THE DIAGNOSTIC CATHETER AND SUCCESSFULLY FLUSHED. NEITHER LEAKAGE NOR ANY ANOMALY OBSERVED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT ¿DIAGNOSTIC CARDIOLOGY CATHETER-CATHETER (BODY/SHAFT)- LEAKAGE¿ WAS NOT CONFIRMED SINCE THE CATHETER WAS SUCCESSFULLY FLUSHED DURING ANALYSIS. THE EXACT CAUSE OF THE DIFFICULTY EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE DHR REVIEW RESULTS NOR THE ANALYSIS SUGGEST THAT THE FAILURE EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S GENDER IS UNKNOWN. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PREPPING OF A 5F INFINITI DIAGNOSTIC CATHETER, IT WAS REPORTED, THAT LEAKAGE WAS FOUND. THE PRODUCT WAS EXCHANGED FOR ANOTHER SAME LIKE PRODUCT. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290084 CATH 5F INFINITI TL JR4.0 100C DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15870973

    Patients

    Seq Age Sex Outcome Treatment
    1