BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PROWLER CATALOG NUMBER

    MDR report key: 2810211 · Received October 31, 2012

    Report

    Report Number
    1058196-2012-00400
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 10, 2012
    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

    DURING A COIL EMBOLIZATION OF AN INTERNAL CAROTID--POSTERIOR CEREBRAL ARTERY ANEURYSM WHILE ADVANCING THE ENTERPRISE VRD (ENC451412/10131776) IN AN UNSPECIFIED PROWLER SELECT, THERE WAS SEVERE RESISTANCE ENCOUNTERED AT THE HUB OF THE MICROCATHETER. BOTH THE VRD AND PROWLER WERE REMOVED FROM THE PATIENT AS A UNIT. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES; ANOTHER ENTERPRISE VRD WAS USED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY WAS REPORTED. ONCE THE ENTERPRISE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN DEPLOYED THE VRD. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WERE NOTED ON EITHER THE MICROCATHETER OR VRD BY VISUAL INSPECTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THERE WERE NO DAMAGE/DEFECTS NOTED ON THE DEVICES AFTER THE EVENT. THE PROWLER SELECT MICROCATHETER AND ENTERPRISE VRD ARE NOT AVAILABLE FOR ANALYSIS AND NO FURTHER INFORMATION IS AVAILABLE. THE LOT NUMBER OF THE PROWLER SELECT PLUS IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. (B)(4) MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF ENTERPRISE LOT 10131776. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4) MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE RETURN OF THE INVOLVED DEVICES FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE RESISTANCE ENCOUNTERED AT THE HUB OF THE PROWLER MICROCATHETER WITH ATTEMPT TO INSERT THE ENTERPRISE. THE INTRODUCTION PROCEDURE IS TECHNIQUE DRIVEN; REQUIRING PROPER ORIENTATION AND POSITIONING OF EACH COMPONENT OF THE SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE. IF PRIOR TO INTRODUCTION OF THE STENT FULLY WITHIN THE MICROCATHETER, THE INTRODUCER IS NOT FULLY SEATED IN THE HUB OR THERE IS BACKWARD MOVEMENT OF THE INTRODUCER, THE DISTAL OR PROXIMAL END OF THE STENT WILL EXPAND AS IT ENTERS THE GAP. THIS WILL RESULT IN SOME NOTICEABLE RESISTANCE. THE GREATER THE GAP THE GREATER THE RESISTANCE WILL BE. PROCEDURALLY THE PROWLER MICROCATHETER WOULD HAVE BEEN POSITIONED AT THE TARGET SITE OVER A GUIDEWIRE PRIOR TO INSERTION OF THE ENTERPRISE VRD AND THERE WAS NO REPORTED RESISTANCE RELATED TO THIS PROCESS. ADDITIONALLY, AS REPORTED, AFTER REMOVAL THE ENTERPRISE VRD WAS ABLE TO BE DEPLOYED OUT OF THE INTRODUCER. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION OF INTERNAL CAROTID-POSTERIOR CEREBRAL ARTERY ANEURYSM. A CHARACTERISTIC OF THE VESSEL WAS NOT PROVIDED. DURING THE PROCEDURE, WHILE ADVANCING A VRD ((B)(4), COMPLAINT PRODUCT) IN AN UNSPECIFIED PROWLER SELECT, THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE AT THE HUB OF THE MICROCATHETER. BOTH THE VRD AND PROWLER WERE REMOVED FROM THE PATIENT AS A UNIT. AFTERWARDS, THE PROCEDURE WAS COMPLETED USING ANOTHER VRD WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY WAS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON BOTH THE MC AND THE VRD BY VISUAL INSPECTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THERE WERE NO DAMAGE/DEFECTS NOTED ON THE DEVICES AFTER THE EVENT. PLEASE NOTE THAT ONCE THE ENTERPRISE WAS OUT OF THE PATIENT'S BODY, THE PHYSICIAN DEPLOYED THE VRD FOR UNKNOWN PURPOSE. NO PRODUCT IS AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1