BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3122838 · Received May 21, 2013

    Report

    Report Number
    1058196-2013-00145
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Removal / Correction Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: AN INCORRECT DEVICE CATALOG AND LOT NUMBER WAS INADVERTENTLY REPORTED UNDER THE INITIAL 3500A SUBMISSION. BELOW PLEASE FIND CORRECTIONS: "BRAND NAME" IT SHOULD BE "ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM." "COMMON DEVICE NAME" IT SHOULD BE "CNV ENTERPRISE SES (NJE)." "CATALOG NUMBER " IT SHOULD BE "ENF452812", LOT "10136308", MANUFACTURING DATE SHOULD BE 06/2012 AND EXPIRATION DATE 05/05/2014. ALL OTHER CORRECTIONS ARE NOTED IN THIS FOLLOW UP REPORT. OTHER INFORMATION PROVIDED ARE CORRECT UNLESS OTHERWISE INDICATED. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A MIDDLE CEREBRAL ARTERY (MC) BIFURCATION PROCEDURE, THE ENTERPRISE VRD 45X28X12MM (ENF452812/10136308) DIDN'T DEPLOY AT THE ANEURYSM NECK. THE ENTIRE ENTERPRISE SYSTEM WAS REMOVED WITH THE FIRST PROWLER SELECT PLUS 45 DEGREE MICROCATHETER (DETAILS UNKNOWN). IT WAS REPORTED THAT THERE IS NO INFORMATION REGARDING VESSEL CHARACTERISTICS. THE MICROCATHETER WAS PLACED DISTAL TO THE TARGET SITE PRIOR TO ADVANCEMENT OF THE ENTERPRISE TO THE TARGET SITE FOLLOWED BY WITHDRAWAL OF THE MICROCATHETER TO DEPLOY THE DEVICE. THE MICROCATHETER WAS CHANGED TO ANOTHER PROWLER SELECT PLUS 45 DEGREE MICROCATHETER (DETAILS UNKNOWN) BUT THE ENTERPRISE STILL DID NOT DEPLOY. THE STENT WAS CHANGED TO ANOTHER ENTERPRISE VRD AND DELIVERY SYSTEM 45X28X12MM (DETAILS UNKNOWN) AND WAS DEPLOYED SUCCESSFULLY WITH THE SECOND PROWLER SELECT PLUS 45 DEGREE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH BOTH MICROCATHETERS WITH THE FIRST STENT. THERE WERE NO DAMAGES NOTED EITHER MICROCATHETER PRIOR TO AND AFTER USE WITH THE FIRST STENT. THERE WERE NO DAMAGES NOTED ON THE FIRST STENT PRIOR TO AND AFTER USE. THE MICROCATHETER WAS NOT RESHAPED. IT WAS REPORTED THAT THERE WERE NO PROBLEMS WITH THE MICROCATHETERS. THE PHYSICIAN DID DEPLOYMENT AS OUTLINED IN THE THROUGH INSTRUCTION HOW TO USE ENTERPRISE STENT. IT WAS INDICATED THAT THERE WAS NO POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE EVENT. (B)(4): THE FIRST PROWLER SELECT PLUS MICROCATHETER USED IN ATTEMPT TO DEPLOY THE ENTERPRISE STENT WAS NOT RETURNED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE MICROCATHETER TO THE INABILITY TO DEPLOY THE STENT; HOWEVER, IT WAS REPORTED THE SAME ENTERPRISE COULD NOT BE DEPLOYED THROUGH A SECOND PROWLER SELECT PLUS WHICH WAS THEN USED SUCCESSFULLY WITH ANOTHER ENTERPRISE. A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AS THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4): A NON-STERILE UNIT OF ENTERPRISE VRD AND DELIVERY SYSTEM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DELIVERY WIRE WAS RECEIVED INSIDE OF INTRODUCER TUBE; SALINE SOLUTION WAS OBSERVED INSIDE THE INTRODUCER TUBE AND OVER THE DELIVERY WIRE. THE STENT WAS RECEIVED POSITIONED ON THE DELIVERY WIRE. A STRETCHED CONDITION WAS OBSERVED ON THE DELIVERY WIRE DISTAL SECTION. FUNCTIONAL ANALYSIS WAS PERFORMED ACCORDING TO PROCEDURE; A MICROCATHETER (PROWLER SELECT) LAB SAMPLE WAS USED AS THE CONCOMITANT MICROCATHETERS WERE NOT RETURNED. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DELIVERY WIRE THROUGH THE MICROCATHETER. ONCE THE DELIVERY WIRE WAS RETRIEVED FROM THE INTRODUCER TUBE A FRACTURE WAS OBSERVED AT 5CM FROM DISTAL TIP, ANOTHER OTHER FRACTURE WAS OBSERVED AT 23CM FROM DISTAL TIP, AT THE POINT WHERE THE STRETCHED CONDITION WAS OBSERVED DURING INITIAL VISUAL ANALYSIS. THE DEVICE WAS INSPECTED UNDER VISION SYSTEM AND A STRETCHED CONDITION WAS OBSERVED IN COIL WIRE SECTION AT 23 CM FROM DISTAL TIP AND THE CORE WIRE WAS OBSERVED FRACTURED, ANOTHER FRACTURE WAS OBSERVED AT 5CM FROM DISTAL TIP. A SEM ANALYSIS WAS PERFORMED IN ORDER TO FURTHER INVESTIGATION THE FRACTURED AREAS. THE FIRST CORE WIRE FRACTURE SURFACE PRESENTED WITH EVIDENCE OF CHEMICAL ATTACK AND MELT SURFACE CONDITIONS; IN ADDITION, FLATTENED SECTIONS WERE OBSERVED NEAR THE CORRODED AREA. THIS FLATTENED SECTIONS SUGGESTS AN OVERLOAD AND/ OR FATIGUE EVENT PRIOR TO THE SEPARATION. THE SECOND FRACTURE SHOWED CLEAR EVIDENCE OF CHEMICAL ATTACK (POROSITY). TIN AND SILVER WERE FOUND ON THE CORRODED AREA; (B)(4). THERE IS NO CLEAR EVIDENCE OF THE SOURCE OF THE OTHER VARIOUS FOUND ELEMENTS. ACCORDING TO THE OBSERVED SURFACE CHARACTERISTICS CUTTING WAS DISCARDED AS THE ROOT CAUSE. FURTHER ANALYSIS WAS PERFORMED BY LAKE REGION AND THE RESULTS OBTAINED DURING THE INITIAL SEM ANALYSIS WERE CONFIRMED BY LAKE REGION. DURING THE ANALYSIS PERFORMED BY LAKE REGION THE SAMPLE WAS FOUND FRACTURED IN SEVERAL PIECES. THERE WAS NOTED CORROSION ASSOCIATED WITH THE AREAS OF FRACTURE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10081341. 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 LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE CAUSE OF THE REPORTED INABILITY TO DEPLOY THE STENT CANNOT BE DETERMINED. BASED ON THE DELIVERY WIRE WITH THE STENT POSITIONED ON THE DELIVERY WIRE FOUND FULLY WITHIN THE INTRODUCER, POST PROCEDURAL CORROSION AND OVERLOAD/FATIGUE APPEARS TO HAVE CONTRIBUTED TO THE POST PROCEDURAL FRACTURES WITH FUNCTIONAL TESTING. THE DEVICE WOULD NOT HAVE BEEN ABLE TO BE RECAPTURED WITHIN THE INTRODUCER IF THESE FINDINGS HAD BEEN PRESENT DURING PROCEDURAL USE. THE CAUSE OF THE INABILITY TO ADVANCE THE DEVICE OUT OF THE INTRODUCER AS RECEIVED WAS RELATED TO THE FRACTURES WHICH BASED ON THE REPORTED INFORMATION AND ANALYSIS WOULD HAVE OCCURRED POST PROCEDURAL USE AND APPEAR TO BE RELATED TO POST PROCEDURAL CHEMICAL EXPOSURE. THE EXACT CAUSE OF THE MENTIONED CHEMICAL ATTACK COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, BASED ON THE ANALYSIS AND TIMEFRAMES MENTIONED IN THE LAKE REGION, THIS APPEARS TO HAVE SIMILAR POST PROCEDURAL USE FAILURE MODE AS ADDRESSED IN PREVIOUS INVESTIGATION OPENED VIA THE RISK MANAGEMENT PROCESS. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ENTERPRISE VRD AND DELIVERY 45X28X12MM (ENF452812/10136308) DIDN'T DEPLOY AT THE ANEURYSM NECK. THE ENTIRE ENTERPRISE SYSTEM WAS REMOVED WITH THE FIRST PROWLER SELECT PLUS 45 DEGREE MICROCATHETER (DETAILS UNKNOWN). THE MICROCATHETER WAS CHANGED TO ANOTHER PROWLER SELECT PLUS 45 DEGREE MICROCATHETER (DETAILS UNKNOWN) BUT IT ALSO DIDN'T DEPLOY. THE STENT WAS CHANGED TO ANOTHER ENTERPRISE VRD AND DELIVERY 45X28X12MM (DETAILS UNKNOWN) AND WAS DEPLOYED SUCCESSFULLY WITH THE SECOND PROWLER SELECT PLUS 45 DEGREE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH BOTH MICROCATHETERS WITH THE FIRST STENT. THERE WERE NO DAMAGES NOTED ON BOTH MICROCATHETERS PRIOR TO AND AFTER USE WITH THE FIRST STENT. THERE WERE NO DAMAGES NOTED ON THE FIRST STENT PRIOR TO AND AFTER USE. THE MICROCATHETER WAS NOT RESHAPED. THE MICROCATHETER WAS PLACED DISTAL TO THE TARGET SITE PRIOR TO ADVANCEMENT OF THE DEVICE TO THE TARGET SITE FOLLOWED BY WITHDRAWAL OF THE CATHETER TO DEPLOY THE DEVICE. THE PHYSICIAN DID DEPLOYMENT THROUGH INSTRUCTION HOW TO USE ENTERPRISE STENT. THIS IS NOT A POTENTIAL ADVERSE EVENT. THE TARGET VESSEL WAS MCA BIFURCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223804 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ENTERPRISE VRD AND DELIVERY 45X28X12MM