BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM

    MDR report key: 3082999 · Received April 29, 2013

    Report

    Report Number
    9616099-2013-00259
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K060877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PALMAZ BLUE STENT ON AVIATOR PLUS WAS DEPLOYED AS THE PHYSICIAN TOOK THE DEVICE FROM THE PLASTIC CASE AND THE DEVICE COULD NOT BE USED TO TREAT THE PATIENT. THE OUTER PACKAGING WAS NOT DAMAGED. THE DEVICE WAS SECURE IN THE PACKAGING. THE PRODUCT WAS STORED CORRECTLY. THERE WAS NO MISHANDLING OF THE DEVICE. THE PROTECTIVE COVERING OF THE STENT WAS IN PLACE WHEN OPENED. THERE WAS NO OTHER DAMAGE NOTED TO THE DEVICE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT HAS BEEN RECEIVED ON (B)(4) 2013 AND HAS BEEN SENT FOR EVALUATION. ADDITIONAL INFORMATION WILL BE FORTHCOMING WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION UPDATED WITH PRODUCT ANALYSIS: AS REPORTED, THE PALMAZ BLUE STENT ON AVIATOR PLUS WAS DEPLOYED AS THE PHYSICIAN TOOK THE DEVICE FROM THE PLASTIC CASE AND THE DEVICE COULD NOT BE USED TO TREAT THE PATIENT. THE OUTER PACKAGING WAS NOT DAMAGED. THE DEVICE WAS SECURE IN THE PACKAGING. THE PRODUCT WAS STORED CORRECTLY. THERE WAS NO MISHANDLING OF THE DEVICE. THE PROTECTIVE COVERING OF THE STENT WAS IN PLACE WHEN OPENED. THERE WAS NO OTHER DAMAGE NOTED TO THE DEVICE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ONE NON-STERILE PALMAZ BLUE ON AVIATOR PLUS, 5 MM DIAMETER, 50 MM LENGTH, ON 142 CM CATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS RECEIVED EXPANDED; IT APPEARS AS IF THE BALLOON WAS PREVIOUSLY INFLATED AND DEFLATED SINCE RESIDUES OF INFLATION MEDIA WERE NOTED ALONG THE BALLOON. NO OTHER DAMAGES WERE NOTED IN THE DEVICE. 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 ¿STENT/ DISLODGED-PRIOR TO USE¿ WAS NOT CONFIRMED SINCE THE BALLOON WAS PREVIOUSLY INFLATED AND DEFLATED AND RESIDUE OF INFLATION MEDIA WAS NOTED ALONG THE BALLOON. WITH THE INFORMATION PROVIDED AND THE COMPLETED ANALYSIS IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE ANALYSIS TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING OF THE PRODUCT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED, THE STENT WAS DEPLOYED AS SOON AS THE PHYSICIAN TOOK THE DEVICE OUT FROM THE PLASTIC CASE. THEREFORE, THE DEVICE COULD NOT BE USED IT TO PATIENT. THE OUTER PACKAGING WAS NOT DAMAGED. THE DEVICE WAS SECURE IN THE PACKAGING. THE PRODUCT WAS STORED CORRECTLY. THERE WAS NO MISHANDLING OF THE DEVICE. THE PROTECTIVE COVERING OF THE STENT WAS IN PLACE WHEN OPENED. THERE WAS NO OTHER DAMAGE NOTED TO THE DEVICE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184144 PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM ENDOVASCULAR SDS/STENTS FGE CORDIS DE MEXICO NA 15646393

    Patients

    Seq Age Sex Outcome Treatment
    1