BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRE-SHAPED PROWLER MICROCATHETERS

    MDR report key: 3012805 · Received March 20, 2013

    Report

    Report Number
    1058196-2013-00076
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K003925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE PROWLER-14 DMB J SHAPE MICROCATHETER (B)(4) WAS USED WITH AN EXCHANGED GUIDEWIRE TO OBTAIN SUITABLE POSITION TO DEPLOY A STENT IN THE ACOM, BUT WITHDRAWAL, THE WIRE BECAME STUCK ON THE MICROCATHETER AND WOULD NOT MOVE PULLING THE WHOLE SYSTEM OUT OF THE PATIENT. THERE WAS SOME DELAY TO THE CASE AND THE PATIENT WILL NEED TO BE BROUGHT BACK TO BE TREATED AGAIN, AS ALL OTHER OPTIONS WERE EXHAUSTED ON THE DAY TO NO AVAILABLE, BUT THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. THERE WAS NO ADVERSE EVENT REPORTED, AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 15171411 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE DEVICE, THE REPORTED EVENT OF RESISTANCE COULD NOT BE CONFIRMED. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    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 15171411 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PROWLER-14 DMB J SHAPE MICROCATHETER (606151JX/ 15171411) WAS USED WITH AN EXCHANGED GUIDEWIRE TO OBTAIN SUITABLE POSITION TO DEPLOY A STENT IN THE ACOM, BUT WITHDRAWAL, THE WIRE BECAME STUCK ON THE MICROCATHETER AND WOULD NOT MOVE PULLING THE WHOLE SYSTEM OUT OF THE PATIENT. THERE WAS SOME DELAY TO THE CASE AND THE PATIENT WILL NEED TO BE BROUGHT BACK TO BE TREATED AGAIN, AS ALL OTHER OPTIONS WERE EXHAUSTED ON THE DAY TO NO AVAILABLE, BUT THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. THERE WAS NO ADVERSE EVENT REPORTED, AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116484 PRE-SHAPED PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15171411

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR UNKNOWN GUIDEWRIE