BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD PTA F7 110 20X40

    MDR report key: 7885359 · Received September 18, 2018

    Report

    Report Number
    9616099-2018-02396
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 24, 2018
    Report Date
    October 3, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    KNQ
    PMA / PMN Number
    K023907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER OPENING THE PACKAGING OF 2 7F MAXI LD 110 20X40 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS, THE USER FOUND THE INNER STERILE PACKAGING WAS ¿LEAKING.¿ THERE WAS NO REPORTED PATIENT INJURY. WHEN REMOVING THE PACKAGE, IT WAS NOTED THAT THE INNER PACKAGE LEAKED BEFORE BEING USED. THE SEAL OF THE INNER PACKAGE WAS NOT OPENED. THE PRODUCT WAS STORED IN THE LAB. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE PRODUCT WAS NOT USED. CASE-(B)(4): TWO NON-STERILE UNIT OF MAXI LD PTA F7 110 20X40 WERE RECEIVED COILED INSIDE A PLASTIC BAG. NO ORIGINAL INNER/OUTER PACKAGING WAS RETURNED FOR ANALYSIS. THE DEVICE IDENTIFIED AS NUMBER 2 WAS ASSIGNED TO THIS PRODUCT EVALUATION FILE. DEVICE # 2 WAS VISUALLY INSPECTED AND SEVERAL KINK/BENT CONDITIONS WERE OBSERVED AT 26, 56 AND 89 CM FROM THE DISTAL TIP. THE BALLOON WAS RECEIVED INSIDE THE PROTECTIVE TUBE. NO OTHER DAMAGES OR ANOMALIES WERE FOUND. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17711136 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 COMPROMISED STERILITY STERILE BARRIER BREACHED¿ COULD NOT BE CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICES SINCE THE PRODUCTS¿ INNER POUCHES WERE NOT RECEIVED. THE EXACT CAUSE OF THE ISSUE EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE CUSTOMER. HOWEVER, THE KINKED CONDITIONS FOUND MAY BE DUE TO HANDLING DURING SHIPPING FOR ANALYSIS SINCE NONE OF THE PACKAGING WAS RECEIVED. AS WARNED IN THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿DO NOT USE OPEN OR DAMAGED PACKAGES.¿ NEITHER THE PRODUCT ANALYSES NOR THE DHR REVIEWS SUGGESTS THAT THE EVENT REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS ASSOCIATED WITH THE REPORTED EVENT AND THE RELATED REPORT NUMBER IS 9616099-2018-02395.

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(6). THE DEVICE WAS RETURNED BUT THE ENGINEERING REPORT IS PENDING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS ASSOCIATED WITH THE REPORTED EVENT AND THE RELATED REPORT NUMBER IS 9616099-2018-02395.

    Description of Event or Problem · 1

    AFTER OPENING THE PACKAGING OF 2 7F MAXI LD 110 20X40 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS, THE USER FOUND THE INNER STERILE PACKAGING WAS ¿LEAKING.¿ THE DEVICES WILL BE RETURNED FOR ANALYSIS. THERE WAS NO REPORTED PATIENT INJURY. WHEN REMOVING THE PACKAGE, IT WAS NOTED THAT THE INNER PACKAGE LEAKED BEFORE BEING USED. THE SEAL OF THE INNER PACKAGE WAS NOT WAS OPENED. THE PRODUCT WAS STORED IN THE LAB. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728109 MAXI LD PTA F7 110 20X40 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER KNQ CORDIS CASHEL N/A 17711136

    Patients

    Seq Age Sex Outcome Treatment
    1