BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2103019 · Received May 25, 2011

    Report

    Report Number
    1058196-2011-00249
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE ENTERPRISE STENT WOULDN`T ADVANCE IN THE MIDDLE SECTION OF THE PROWLER SELECT PLUS MICROCATHETER, AFTER THE EVENT, THE MICROCATHETER AND ENTERPRISE SYSTEM WERE REMOVED AS A UNIT. ANOTHER STENT AND MICROCATHETER WERE SUCCESSFULLY PLACED AT THE DESIRED LOCATION. THERE WAS NO ADVERSE EVENT. (B)(4): ONE PROWLER SELECT PLUS MICROCATHETER POUCH WAS RECEIVED FOLDED INSIDE OF A PLASTIC BAG. THE MICROCATHETER WAS NOT RECEIVED. PROCEDURALLY, PRIOR TO THE EVENT, THE MICROCATHETER WOULD HAVE BEEN ADVANCED TO THE TARGET SITE OVER A GUIDEWIRE. BASED ON NO REPORTED DIFFICULTY WITH ADVANCEMENT OF THE MICROCATHETER OVER A GUIDEWIRE, IT IS POSSIBLE THAT PROCEDURAL FACTORS/VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. WITHOUT THE RETURN OF THE MICROCATHETER FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE INABILITY TO ADVANCE THE CONCOMITANT ENTERPRISE VRD THROUGH THE LUMEN. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00249 AND 1058196-2011-00250.

    Additional Manufacturer Narrative · 1

    DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE ENTERPRISE STENT WOULDN`T ADVANCE IN THE MIDDLE SECTION OF THE PROWLER SELECT PLUS MICROCATHETER, AFTER THE EVENT, THE MICROCATHETER AND ENTERPRISE SYSTEM WERE REMOVED AS A UNIT. ANOTHER STENT AND MICROCATHETER WERE SUCCESSFULLY PLACED AT THE DESIRED LOCATION. THE PRODUCT WILL BE RETURNED FOR ANALYSIS AND THERE WAS NO ADVERSE EVENT WITH THE EVENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00249 AND 1058196-2011-00250. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00249 AND 1058196-2011-00250. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    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. REVIEW OF LOT 15250422 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE 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 15250422. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00249 AND... THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE STENT WOULDN'T ADVANCE IN ABOUT THE MIDDLE OF THE MICROCATHETER, SO THE SURGEON EXCHANGE THE STENT AND MICROCATHETER TO SUCCESSFULLY PLACE ANOTHER STENT AT THE DESIRED LOCATION. THE PRODUCT WILL BE RETURNED FOR ANALYSIS AND THERE WAS NO ADVERSE EVENT WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15250422

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE STENT