BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 2112532 · Received June 3, 2011

    Report

    Report Number
    9616099-2011-00379
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THE VISTA BRITE GUIDE CATHETER HAD COMPROMISED STERILITY. THE INNER POUCH ON A VISTA BRITE TIP GUIDING CATHETER WAS NOT FULLY SEALED, STERILITY WAS POSSIBLY COMPROMISED. WHEN THE PHYSICIAN TOOK THE PRODUCT FROM OUTER PACKAGE, HE FOUND THE INNER POUCH WAS NOT FULLY SEALED. THE PRODUCT WAS NOT USED CLINICALLY AND THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON STERILE UNIT OF GC VISTA BRITE TIP 6F .070" WAS RECEIVED FOLDED IN ITS ORIGINAL POUCH. THE MYLAR POUCH AND INNER LABEL HAVE EVIDENCE THAT THEY WERE TORN APART FROM THE TYVEK POUCH AND THESE COMPONENTS PORTIONS WERE MISSING WHEN PRODUCT WAS RECEIVED FOR ANALYSIS AT FAL. PRODUCT WAS EXPOSED; THE "PROXIMAL END" SEGMENT OF THE CATHETER WAS OUT OF THE MOUNTING CARD AND PACKAGE. THE POUCH AND INNER LABEL WERE DAMAGED AT THE SAME PLACES WHERE THE SEAL WAS SLIT; ORANGE COLOR STAINS WERE DETECTED AT SEVERAL PLACES OF POUCH; ALSO THE POUCH HAD SOME CHARACTERS WRITTEN WITH BLUE PEN. TYVEK AND MYLAR WERE VISUALLY INSPECTED LOOKING FOR EVIDENCE OF PACKAGE WAS ORIGINALLY SEALED AND RESULTS SHOWS THAT THERE ARE REGULAR SEAL MARKS AT CHEVRON AND SIDE SEAL AREAS THAT CONFIRM THAT THE PRODUCT'S PACKAGE WAS INITIALLY PROPERLY SEALED. CATHETER WAS ALSO KINKED AT 29.4 CM, 53.5 CM, 57.4 CM, 84.0 CM, 85.0 CM, AND 86.0 CM FROM DISTAL END. DIMENSIONAL ANALYSIS WAS PERFORMED PER DRAWING (B)(4). CHEVRON AND SIDE SEAL WIDTH MARKS (REDUCTION IN EFFECTIVE CROSS-SECTION AREA) WERE MEASURE AT POUCH COMPONENT AND BOTH WERE FOUND WITHIN SPECIFICATION. THE PORTION OF POUCH THAT WAS TORN APART COULD NOT BE EVALUATED (MEASURED) BECAUSE IT WAS MISSING WHEN PRODUCT WAS RECEIVED FOR ANALYSIS. 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 COMPLAINT REPORTED BY THE CUSTOMER "POUCH-COMPROMISED STERILITY-SEAL OPEN WAS CONFIRMED DUE TO THE CONDITION OF POUCH/PACKAGE AS RECEIVED." HOWEVER, THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS; EVIDENCE OF THAT PRODUCT'S PACKAGE WAS INITIALLY PROPERLY SEALED WAS FOUND DURING THE VISUAL ANALYSIS. NEITHER THE ANALYSIS NOR THE DHR REVIEW RESULTS SUGGEST THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS; HANDLING AND MANIPULATION OF THE PRODUCT/PACKAGE AFTER THE MANUFACTURING AND TRANSPORTATION CONTROLS MAY CONTRIBUTE TO THE FAILURE AS REPORTED. THE CAUSE OF THE KINKS DETECTED ON CATHETER'S BODY COULD BE RELATED TO THE UNIT PACKAGE PROCESS FOR RETURN. CONTROLS ARE IN PLACE TO VERIFY THE CATHETER FOR POUCH STERILITY, DAMAGES AND CONTAMINATION ON PACKAGE; THE PRODUCED CATHETERS ARE INSPECTED 100 % BEFORE LEAVING THE FACILITY. ALSO, SEVERAL INSPECTIONS ARE PERFORMED AT THE FINAL PACKAGING OPERATION. (B)(4), THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPLAINT REPORTED BY THE CUSTOMER "POUCH-COMPROMISED STERILITY-SEAL OPEN WAS CONFIRMED DUE TO THE CONDITION OF POUCH/PACKAGE AS RECEIVED". HOWEVER, THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS; EVIDENCE OF THAT PRODUCT'S PACKAGE WAS INITIALLY PROPERLY SEALED WAS FOUND DURING THE VISUAL ANALYSIS. NEITHER THE ANALYSIS NOR THE DHR REVIEW RESULTS SUGGEST THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS; HANDLING AND MANIPULATION OF THE PRODUCT/PACKAGE AFTER THE MANUFACTURING AND TRANSPORTATION CONTROLS MAY CONTRIBUTE TO THE FAILURE AS REPORTED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT HANDLING AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE INNER POUCH ON A VISTA BRITE TIP GUIDING CATHETER WAS NOT FULLY SEALED, STERILITY WAS POSSIBLY COMPROMISED. WHEN THE PHYSICIAN TOOK THE PRODUCT FROM OUTER PACKAGE, HE FOUND THE INNER POUCH WAS NOT FULLY SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15186692

    Patients

    Seq Age Sex Outcome Treatment
    1