BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 4324099 · Received December 11, 2014

    Report

    Report Number
    1058196-2014-00308
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 22, 2014
    Report Date
    January 6, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4). THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS REPORTED UNDER COMPLAINT NO. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE STENT (ENF452812/1041516) DID NOT ADVANCED IN THE PROWLER SELECT (MC) MICROCATHETER DURING USE IN THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENTS WILL BE RETURNED FOR ANALYSIS. A NON-STERILE PROWLER SELECT PLUS 150/5CM 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 NO DAMAGES WERE NOTED ON IT JUST RESIDUES OF DRY BLOOD CAN BE OBSERVED ON THE DEVICE. THE ID FROM THE MICRO-CATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE MICRO-CATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND RESIDUES OF DRY BLOOD WERE EXPULSED FROM THE DISTAL TIP OF THE RECEIVED DEVICE. AFTER THAT A 0.018¿ A GUIDE WIRE LAB SAMPLE WAS INTRODUCED INTO THE MICRO-CATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP. AFTER THAT THE MICRO-CATHETER WAS FLUSHED AGAIN AND A LAB SAMPLE ENTERPRISE WAS INTRODUCED INTO THE MICRO-CATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP WITHOUT ANY DIFFICULTY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 17020949 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO 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 COSTUMER COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR ANALYSIS.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE ENTERPRISE STENT (ENF452812/1041516) DID NOT ADVANCED IN THE PROWLER SELECT (MC) MICROCATHETER DURING USE IN THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENTS WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806150 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CODMAN AND SHURTLEFF, INC 17020949

    Patients

    Seq Age Sex Outcome Treatment
    1