BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 2132646 · Received June 17, 2011

    Report

    Report Number
    9616099-2011-00427
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S90
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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. REVIEW OF LOT 15290627 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NONCONFORMANCES: NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. PROCESS MONITORING: NO EXCURSIONS WERE FOUND FOR LOT 15290627. THE OPERATOR QUALIFICATION RECORDS FOR LOAD COMPONENTS, ACCORDING TO (B)(4) WERE REVIEWED. THE OPERATORS THAT PERFORMED THIS OPERATION WERE QUALIFIED ON THE APPROPRIATE MANUFACTURING WORK INSTRUCTION REVISION AT THE TIME OF THE LOT MANUFACTURING. THE RECEIVING INSPECTION RECORDS FOR THE USED POUCH (LOT: 201010120001) WERE REVIEWED, AND THIS LOT WAS DEEMED ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED; THEREFORE, WAS UPDATED. WHEN THE PHYSICIAN TOOK THE PRODUCT FROM THE OUTER PACKAGE, HE FOUND THERE WAS FOREIGN MATTER IN THE INNER POUCH. THE INNER POUCH WAS NOT OPENED. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING OR THE DEVICE PRIOR TO USE. THE ISSUE WAS DETECTED BEFORE USE ON THE PATIENT. ONE UNIT OF (B)(4) FIRE STAR, 2.00 X 10 WAS RECEIVED IN THE STERILE PACKAGING. THE OUTER BOX WAS OPENED AND INNER POUCH WAS CLOSED. THE PRODUCT WAS FOUND PLACED IN ITS CORRECT POSITION. FOREIGN MATERIAL WAS FOUND INSIDE THE POUCH. NO OTHER DAMAGES WERE NOTED. THE FOREIGN MATERIAL WAS MEASURED AND IT WAS FOUND OUT OF SPECIFICATION. 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 FAILURE "FOREIGN MATERIAL" WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED HOWEVER IT APPEARS TO BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT. A RISK ASSESSMENT HAS BEEN INITIATED TO EVALUATE THIS ISSUE.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN TOOK THE PRODUCT FROM THE OUTER PACKAGE, HE FOUND THERE WAS FOREIGN MATTER IN THE INNER POUCH. THE INNER POUCH WAS NOT OPENED. THE DEVICES WILL BE RETURNED FOR INVESTIGATION. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING OR THE DEVICE PRIOR TO USE. THE ISSUE WAS DETECTED BEFORE USE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRE STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 15290627

    Patients

    Seq Age Sex Outcome Treatment
    1