BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 2140658 · Received June 27, 2011

    Report

    Report Number
    1058196-2011-00334
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WAS A HUGE RESISTANCE IN THE PROXIMAL SECTION OF THE PROWLER 14 MICROCATHETER DURING ADVANCEMENT OF THE ENTERPRISE VRD. THEREFORE, THE MICROCATHETER WAS CHANGED LOSING TARGET SITE ACCESS; HOWEVER, THE SAME ENTERPRISE SYSTEM WAS USED SUCCESSFULLY WITH THE NEW MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. THE TARGET LESION LOCATION AND VESSEL CHARACTERISTICS ARE UNKNOWN. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE MICROCATHETER WAS NOT RE-SHAPED PRIOR TO USE. THE EVENT OCCURRED DURING THE INITIAL INSERTION TO THE TARGET SITE. THERE WAS CONSTANT FLUOROSCOPY THROUGHOUT THE PROCEDURE. NO ADDITIONAL TORQUE OR MANIPULATION WAS USED ONCE THE SDS MET THE RESISTANCE AND WOULD NOT GO THROUGH THE MICROCATHETER. IT WAS NOTED THAT THERE WERE NO KINKS OR BENDS NOTED TO THE GUIDEWIRE (BOSTON) OR THE MICROCATHETER. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. 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. A NON-STERILE PROWLER 14 WAS RECEIVED TANGLED INSIDE OF A PLASTIC BAG. THE DEVICE WAS INSPECTED AND SEVERAL KINKS WERE NOTED ALONG THE BODY ALSO AN ELONGATION CONDITION CAN BE OBSERVED AND THE DEVICE WAS RECEIVED BROKEN AT 132CM FROM HUB. THE REST OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MICROCATHETER WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND BROKEN (CUT) AT 132CM FROM THE HUB. WITH FOLLOW-UP INVESTIGATION IT WAS REPORTED THAT IT WAS POSSIBLE THAT AFTER WITHDRAWING, BECAUSE OF THE FRICTION, THE PHYSICIAN CUT THE CATHETER SO THAT THE SAME ENTERPRISE COULD BE USED TO COMPLETE THE PROCEDURE. THE ID FROM THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE THE CONDITIONS OF THE DEVICE WAS RECEIVED (SEVERAL KINKS, ELONGATION CONDITION AND BROKEN.) ADDITIONALLY THE FUNCTIONAL TEST COULD NOT BE PERFORMED WITH THE PROWLER 14, SINCE PER THE INSTRUCTIONS FOR USE (IFU); THE ENTERPRISE IS DESIGNED FOR USE WITH THE PROWLER SELECT PLUS, SPECIFIED AS HAVING A 0.021'' INNER DIAMETER. THE PROWLER 14 THAT WAS USED HAS AN INNER DIAMETER OF 0.0165. THERE WAS NO REPORT OF ANY SEPARATION OF THE MICROCATHETER BY THE USER AND IT WAS REPORTED THAT THERE WERE NO OTHER DAMAGES TO THE DEVICE AFTER REMOVAL AND IT MAY HAVE BEEN INTENTIONALLY CUT BY THE USER AFTER REMOVAL FROM THE PATIENT. THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION THAT THE ENTERPRISE VRD WAS BEING ADVANCED INTO A PROWLER 14 MICROCATHETER WHICH HAS AN ID LESS THAN THE SIZE INDICATED IN THE IFU FOR USE WITH THE ENTERPRISE, THE CAUSE OF THE REPORTED RESISTANCE WAS DUE TO INAPPROPRIATE DEVICE SELECTION WITH NO INDICATION OF ANY RELATED DEVICE MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT DURING ADVANCEMENT OF THE ENTERPRISE SDS THERE WAS A HUGE RESISTANCE IN THE PROXIMAL SECTION OF THE MICROCATHETER. THEREFORE THE PHYSICIAN CHANGED THE MICROCATHETER, LOSING TARGET SITE ACCESS, AND INSERTED ANOTHER DEVICE TO CONTINUE THE PROCEDURE. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. TARGET LESION LOCATION AND VESSEL CHARACTERISTICS ARE UNKNOWN. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE EVENT OCCURRED DURING THE INITIAL INSERTION TO THE TARGET SITE. THERE WAS CONSTANT FLUOROSCOPY THROUGHOUT THE PROCEDURE. NO ADDITIONAL TORQUE OR MANIPULATION WAS USED ONCE THE SDS MET THE RESISTANCE AND WOULD NOT GO THROUGH THE MICROCATHETER. IT WAS NOTED THAT THERE WERE NO KINKS OR BENDS NOTED TO THE GUIDEWIRE (BOSTON) OR THE MICROCATHETER. AFTER THE EVENT OCCURRED THE PHYSICIAN CHANGED THE MICROCATHETER. WHEN CHANGING THE DEVICE, TARGET SITE ACCESS WAS LOST. THE SAME STENT DELIVERY SYSTEM WAS USED WITH THE NEW MICROCATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13450823

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ENTERPRISE SDS