BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3962079 · Received July 28, 2014

    Report

    Report Number
    1058196-2014-00201
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    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

    THE ENTERPRISE STENT (B)(4) WAS NOT ADVANCED IN THE PROWLER SELECT PLUS MICROCATHETER (B)(4) AFTER INSERTION INTO HUB. THE STENT AND MICROCATHETER WERE REMOVED TOGETHER AS A UNIT. A DIFFERENT MICROCATHETER (DETAILS UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE STENT OR MICROCATHETER AFTER USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TARGET VESSEL WAS RT. DISTAL ICA WHICH WAS NOT CALCIFIED BUT MILDLY TORTUOUS. A NON-STERILE SELECT PLUS 150/5 CM 45 SHAPE WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HUB WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE BODY OF THE DEVICE WAS INSPECTED AND IT WAS FOUND COMPRESSED/KINKED. THE ID FROM THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND AFTER THAT A 0.018¿ A GUIDE WIRE LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP. RESISTANCE/FRICTION WAS FELT WHEN THE GUIDE WIRE WAS PASSING THROUGH OF THE COMPRESSED/KINKED SECTIONS FOUND ON THE MICROCATHETER. AFTER THAT THE MICROCATHETER WAS FLUSHED AGAIN AND A LAB SAMPLE ENTERPRISE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP; RESISTANCE/FRICTION WAS FELT WHEN THE LAB SAMPLE ENTERPRISE WAS PASSING THROUGH OF THE COMPRESSED/KINKED SECTIONS FOUND ON THE MICROCATHETER. REVIEW OF LOT 16046332 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED FAILURE AS ¿CATHETER (BODY/SHAFT) ¿ OBSTRUCTED¿ WAS NOT CONFIRMED DURING THE FUNCTIONAL TEST. THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER APPEARS WAS DUE TO THE COMPRESSED/KINKED SECTIONS FOUND ON THE MICROCATHETER BUT THIS AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 2 REPORTS ASSOCIATED WITH (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT 16046332 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER, IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS 1 OF 2 REPORTS ASSOCIATED WITH (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ENTERPRISE VRD AND DELIVERY (ENF452800/10317228). NEW MICROCATHETER (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    THE ENTERPRISE STENT (ENF452800/10317228) WAS NOT ADVANCED IN THE PROWLER SELECT PLUS MICROCATHETER (606S255FX/16046332) AFTER INSERTION INTO HUB. THE STENT AND MICROCATHETER WERE REMOVED TOGETHER AS A UNIT. A DIFFERENT MICROCATHETER (DETAILS UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE STENT OR MICROCATHETER AFTER USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TARGET VESSEL WAS RT. DISTAL ICA WHICH WAS NOT CALCIFIED BUT MILDLY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437846 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 16046332

    Patients

    Seq Age Sex Outcome Treatment
    1