BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI AVANTI+ .035 F8 W/O GW

    MDR report key: 9280399 · Received November 5, 2019

    Report

    Report Number
    9616099-2019-03323
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 11, 2019
    Report Date
    February 28, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    UDI-DI
    20705032000687
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION DATE OF REPORT (EVENT DESCRIPTION) PER ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    A STERILE UNIT OF ¿SI AVANTI+ .035 F8 W/O GW¿ WAS RECEIVED INSIDE OF A CLEAR PLASTIC BAG, ALONG WITH ANOTHER 13 PRODUCTS. THE PRODUCT WAS RETURNED SEALED IN THE ORIGINAL PACKAGING AND THE STERILITY WAS NOT COMPROMISED. THE DEVICE WAS PLACED ON A TRAY TO PROCEED WITH THE PRODUCT EVALUATION. THE RETURNED UNIT DOES NOT SHOW ANY FOREIGN MATERIAL ON THE HUB AREA OF THE CATHETER SHEATH INTRODUCER (CSI), ONLY THE MEDICAL FLUID IS PRESENT WHICH IS INHERENT TO THE MANUFACTURING PROCESS WAS NOTICED ON THE HUB OF THE CSI. NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE RETURNED PRODUCT. THE MEDICAL FLUID IS BIOCOMPATIBLE, AND THE DEVICES ARE SAFE TO USE. AS PER PRODUCT DESCRIPTION, THE MEDICAL FLUID IS INTENDED TO LUBRICATE THE INTERACTION BETWEEN THE VESSEL DILATOR AND THE GASKET COMPONENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G4, G7, H2 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (B)(4) 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW), ONE 0.035CM 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW), AND 11 UNKNOWN 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN A STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. CASE-2019-00094045-11: THE PRODUCT WAS RETURNED FOR ANALYSIS. A STERILE UNIT OF SI AVANTI+ .035 F8 W/O GW WAS RECEIVED INSIDE OF A CLEAR PLASTIC BAG, ALONG WITH ANOTHER 13 PRODUCTS. PER VISUAL ANALYSIS, THE PRODUCT WAS RETURNED SEALED IN THE ORIGINAL PACKAGING AND THE STERILITY WAS NOT COMPROMISED. THE DEVICE WAS PLACED ON A TRAY TO PROCEED WITH THE PRODUCT EVALUATION. THE RETURNED UNIT DID NOT SHOW ANY FOREIGN MATERIAL ON THE HUB AREA OF THE CSI. NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE RETURNED PRODUCT. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17724983 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿PACKAGING/POUCH/BOX - FOREIGN MATERIAL IN STERILE PACKAGE¿ WERE NOT CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICES. THE RETURNED PRODUCTS DID NOT SHOW ANY FOREIGN MATERIAL. THE UNITS WERE SENT TO PERFORM A FTIR ANALYSIS WITH THE PURPOSE TO CONFIRM THAT ONLY THE MEDICAL FLUID IS PRESENT. RESULTS INDEED CONFIRMED ONLY THE MEDICAL FLUID PRESENCE. THIS FLUID IS BIOCOMPATIBLE, AND THE DEVICES ARE SAFE TO USE. AS PER PRODUCT DESCRIPTION PD0010 THE MEDICAL FLUID IS INTENDED TO LUBRICATE THE INTERACTION BETWEEN THE VESSEL DILATOR AND THE GASKET COMPONENT. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿DO NOT USE IF PACKAGE IS OPEN OR DAMAGED.¿ STANDARD CLINICAL PRACTICE CALLS FOR INSPECTION OF THE DEVICE AND PACKAGING PRIOR TO USE IN THE PATIENT. IF THE USER NOTES ANYTHING UNUSUAL, THEY ARE URGED TO DISCONTINUE USE OF THE DEVICE AND EXCHANGE FOR ANOTHER. NEITHER THE PHR REVIEWS NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENT COULD BE A FAILURE OR DEFECT RELATED THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, TWO 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW), ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW), AND 11 UNKNOWN 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE DEVICES WERE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073860 SI AVANTI+ .035 F8 W/O GW DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION 402608A 17724983 20705032000687

    Patients

    Seq Age Sex Outcome Treatment
    1