BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3884920 · Received June 19, 2014

    Report

    Report Number
    1058196-2014-00180
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLISATION OF RIGHT INTERNAL ILIAC ARTERY PRIOR TO ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. THE VESSEL WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS NAVIGATING A PROWLER SELECT PLUS(606-S255X/15964786) OVER AN UNSPECIFIED GUIDEWIRE (DETAILS UNKNOWN) WHICH DELIVERED THROUGH AN UNSPECIFIED GUIDING CATHETER (DETAILS UNKNOWN) TO THE DESIRED POSITION, IT WAS NOTED THAT HE HAD DIFFICULTY DELIVERING THE MICROCATHETER DUE TO RESISTANCE. ALTHOUGH THE PHYSICIAN FLUSHED THE MICROCATHETER WITH SALINE, THE SITUATION DID NOT IMPROVE. THE REPORT DID NOT INDICATE WHEN AND WHERE EXACTLY IT OCCURRED. IT HASN¿T VERIFIED, BUT ACCORDING TO THE PHYSICIAN, AS HE ATTEMPTED TO DELIVER THE MICROCATHETER TO THE TARGET LESION MANY TIMES, THE HYDROPHILIC COATING OF THE PROWLER SELECT PLUS MIGHT HAVE BEEN PEELED. THEREFORE THE PROWLER SELECT PLUS WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ONE(606-S255X, LOT UNKNOWN), WHICH WAS DELIVERED TO THE TARGET LESION WITHOUT ANY RESISTANCE. THE PROCEDURE WAS CONTINUED USING THE SAME GUIDEWIRE AND GUIDING CATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359932 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15964786

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR