BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1883728 · Received October 27, 2010

    Report

    Report Number
    1058196-2010-00314
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT DURING DELIVERY OF THE 37MM ENTERPRISE VRD ((B)(4)) IT BECAME STUCK NEAR THE PROXIMAL MARKER OF THE PROWLER SELECT PLUS MICROCATHETER ((B)(4)). BECAUSE THE DEVICES WERE STUCK AND COULD NOT BE MOVED, THEY WERE REMOVED FROM THE PATIENT. ANOTHER ENTERPRISE (CATALOG/LOT # UNKNOWN) WAS DELIVERED AGAIN WITH THE SAME MICROCATHETER, HOWEVER THE SAME THING OCCURRED. THEN, ANOTHER ATTEMPT WAS MADE USING THE NEW MICROCATHETER (CATALOG/LOT # UNKNOWN), AND THE SECOND ENTERPRISE WAS SUCCESSFULLY PLACED IN THE TARGET POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EVENT OR NEUROLOGICAL SYMPTOMS. IT IS NOT KNOWN IF THE MICROCATHETER WAS RE-SHAPED BY THE USER. A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED OR FRACTURE, ETC), INTRODUCER OR COIL (UNRAVEL, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC) OR MICROCATHETER, AND THE STENT WAS NOT RECAPTURED. NO FURTHER PROCEDURAL OR CLINICAL INFORMATION IS AVAILABLE. (B)(4). A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. BENT AND COMPRESSED SECTIONS WERE FOUND ON IT. A BEND WAS OBSERVED AT 110CM FROM HUB. COMPRESSED SECTIONS WERE OBSERVED AT 4 AND 17.2CM FROM THE DISTAL END. THE HUB WAS INSPECTED AND NO ANOMALIES WERE FOUND. THE HUB WAS INSPECTED UNDER MICROSCOPE AND NO OBSTRUCTIONS OR ANOMALIES WERE NOTED. AN ENTERPRISE (CORDIS - LAB SAMPLE), WAS INTRODUCED IN TO THE MICROCATHETER AND IT ADVANCE SMOOTHLY; HOWEVER SOME FRICTION WAS EXPERIENCED WHEN IT REACHED THE COMPRESSED SECTIONS; BUT IT COULD CAME OUT OF THE MICROCATHETER'S TIP WITHOUT ANY DIFFICULTY. 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. WITH ANALYSIS OF THE RETURNED MICROCATHETER OBSTRUCTION OF THE DEVICE WAS NOT CONFIRMED. THERE WAS HOWEVER RESISTANCE, WHICH WITH FUNCTIONAL TESTING WAS DUE TO COMPRESSED/BENT SECTIONS OF THE MICROCATHETER. IF THESE CONDITIONS OCCURRED DURING PROCEDURAL USE, IT LIKELY WOULD HAVE IMPACTED THE ABILITY TO INSERT THE ENTERPRISE THROUGH THE MICROCATHETER. PRIOR TO INSERTION OF THE ENTERPRISE THE MICROCATHETER WOULD HAVE BEEN ADVANCED OVER A GUIDEWIRE IN ORDER TO POSITION IT AT THE TARGET SITE; THERE WAS NO REPORTED RESISTANCE DURING THIS PROCEDURAL STEP. HOWEVER, IT WAS ALSO REPORTED THAT NO DAMAGES WERE NOTED ON THE MICROCATHETER AFTER THE EVENT. THEREFORE, THE CAUSE OF THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED OR THE COMPRESSED SECTION FOUND ON THE MICROCATHETER IS RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL FACTORS APPEAR TO BE CONTRIBUTED IN THE EVENT REPORTED AND THE DAMAGES FOUND; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4). ONE NON STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED INSIDE OF PLASTIC BAG. THE STENT WAS RECEIVED INSIDE OF THE INTRODUCER TUBE. NO OTHER VISUAL ANOMALIES WERE OBSERVED. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE. THE STENT AND COIL TIP PRESENTED A FOREIGN MATERIAL OVER THEM. THE FUNCTIONAL ANALYSIS WAS ATTEMPTED TO BE PERFORMED ACCORDING TO PROCEDURE WITH A LAB SAMPLE MICROCATHETER; HOWEVER THE ENTERPRISE WAS NOT ABLE TO GO THROUGH THE MICROCATHETER SINCE THE STENT WAS STUCK IN THE INTRODUCER TUBE. THE STENT WAS REMOVED FROM THE INTRODUCER TUBE AND THE DELIVERY WIRE WITHOUT STENT WAS INTRODUCED IN THE MICROCATHETER WITHOUT ANY DIFFICULTY. X-RAY ANALYSIS WAS PERFORMED IN ORDER TO DETERMINE THE CAUSE OF FOREIGN MATERIAL OBSERVED OVER THE COIL TIP AND STENT; THE RESULTS INDICATE THAT THE LIGHT COLORED DEPOSITED MATERIAL WAS COMPOSED OF CARBON, OXYGEN, SILICON, TIN AND CHLORINE. THE SOLDER ALLOY USED IN THE DISTAL AND IN THE PROXIMAL JOINTS IS 1% TO 5% SILVER AND 95 TO 99% TIN. THE ROOT CAUSE INVESTIGATION INTO THE PRESENCE OF THE FOREIGN MATERIAL FOUND POST DECONTAMINATION ON THE RETURNED PRODUCT DETERMINED THAT THE CONTAMINATE/CORROSION OF THE NON IMPLANTABLE DELIVERY WIRE APPEARS TO BE A CHEMICAL INTERACTION OF THE TIN-BASED SOLDER WITH SALINE SOLUTION AND/OR A CHLORINE-CONTAINING COMPOUND (E.G. TAP WATER). BASED ON THE TEST RESULTS, THE CONTAMINATE/CORROSION RELATED TO EXPOSURE TO THIS CHEMICAL INTERACTION WOULD ONLY OCCUR OVER TIME, POST-PROCEDURE/DECONTAMINATION WITHOUT EFFECT ON THE PROCEDURE OR THE PATIENT. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419843. 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) 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) AND WAS DETERMINED TO BE ACCEPTABLE. THE ENTERPRISE DELIVERY WIRE WAS ABLE TO PASS THROUGH THE MICROCATHETER; HOWEVER, WITH FUNCTIONAL TESTING OF THE ENTERPRISE SYSTEM, IT COULD NOT BE ADVANCED OUT OF THE INTRODUCER DUE TO CONTAMINATE/CORROSION WHICH WAS DETERMINED TO BE DUE TO POST PROCEDURE CHEMICAL INTERACTIONS WITHOUT EFFECT ON THE PROCEDURE OR THE PATIENT. IT WAS REPORTED THAT IN ADDITION TO THE INABILITY TO INSERT THIS ENTERPRISE THROUGH THE MICROCATHETER, A SECOND ENTERPRISE WHICH WAS THEN SUCCESSFULLY INSERTED THROUGH ANOTHER MICROCATHETER, WAS ALSO UNABLE TO BE INSERTED THROUGH THE SAME MICROCATHETER. BASED ON THIS, AND THE ANALYSIS OF THE INVOLVED MICROCATHETER, IT APPEARS PROCEDURAL FACTORS IMPACTING THE MICROCATHETER CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT ANY DEVICE MANUFACTURING RELATED ISSUES CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00314 & 1058196-2010-00315.

    Additional Manufacturer Narrative · 1

    ONE NON STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED INSIDE OF PLASTIC BAG. THE STENT WAS RECEIVED INSIDE OF THE INTRODUCER TUBE. NO OTHER VISUAL ANOMALIES WERE OBSERVED. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND THE STENT AND COIL TIP PRESENTED A FOREIGN MATERIAL OVER THEM. THE FUNCTIONAL ANALYSIS WAS ATTEMPT TO PERFORM ACCORDING TO (B)(4) WITH A MICROCATHETER LAB SAMPLE; HOWEVER THE ENTERPRISE COULD NOT BE ABLE TO GO THROUGH OF THE MICROCATHETER SINCE THE STENT WAS STUCK ON THE INTRODUCER TUBE. THE STENT WAS REMOVED FROM THE INTRODUCER TUBE AND THE DELIVERY WIRE WITHOUT STENT WAS INTRODUCED IN THE MICROCATHETER AND PRESENTED NO DIFFICULTY TO GO THROUGH HIM. X-RAY ANALYSIS WAS PERFORMED IN ORDER TO DETERMINE THE CAUSE OF FOREIGN MATERIAL OBSERVED OVER THE COIL TIP AND STENT; THE RESULTS INDICATE THAT: "(B)(4)". THE ROOT CAUSE INVESTIGATION INTO THE PRESENCE OF THE FOREIGN MATERIAL FOUND POST DECONTAMINATION ON THE RETURNED PRODUCT DETERMINED THAT THE CONTAMINATE/CORROSION OF THE NON IMPLANTABLE DELIVERY WIRE APPEARS TO BE A CHEMICAL INTERACTION (B)(4). BASED ON THE TEST RESULTS, THE CONTAMINATE/CORROSION RELATED TO EXPOSURE TO THIS CHEMICAL INTERACTION WOULD ONLY OCCUR OVER TIME, POST-PROCEDURE WITHOUT EFFECT ON THE PROCEDURE OR THE PATIENT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT (B)(4). 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. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE BY THE CUSTOMER AS STENT DELIVERY WIRE IMPEDED IN MICROCATHETER WAS NOT CONFIRMED SINCE DURING FUNCTIONAL ANALYSIS THE DELIVERY WIRE WAS ABLE TO GO THROUGH THE MICROCATHETER WITHOUT ANY DIFFICULTY. THE CONDITION STENT STUCK ON THE INTRODUCER TUBE COULD BE CAUSED DUE TO THE FOREIGN MATERIAL; HOWEVER, ROOT CAUSE HAS DETERMINED THAT THE CONTAMINATE/CORROSION RELATED TO EXPOSURE TO THIS CHEMICAL INTERACTION WOULD ONLY OCCUR OVER TIME, POST-PROCEDURE WITHOUT EFFECT ON THE PROCEDURE OR THE PATIENT. IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE FAILURE EXPERIENCED DURING THE PROCEDURE. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00314 AND 1058196-2010-00315. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00315. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A CLINICAL STUDY, WHICH IS (B)(6). THE PROCEDURE WAS COIL EMBOLIZATION FOR THE ANEURYSM IN (VA-PICA) VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBELLAR ARTERY THAT WAS NOT CALCIFIED AND MODERATELY TORTUOUS. DURING DELIVERY, THE ENTERPRISE SYSTEM (ENC453712) WAS STUCK NEAR THE PROXIMAL MARKER OF THE MICROCATHETER (606-S255X). AS THE DEVICES WERE STUCK AND COULD NOT BE MOVED, THEY WERE REMOVED FROM THE PATIENT. ANOTHER ENTERPRISE (CATALOG/LOT # UNKNOWN) WAS DELIVERED AGAIN WITH THE SAME MICROCATHETER, HOWEVER, THE SAME THING OCCURRED. THEN, ANOTHER ATTEMPT WAS MADE USING THE NEW MICROCATHETER (CATALOG/LOT # UNKNOWN), AND THE SECOND ENTERPRISE WAS SUCCESSFULLY PLACED IN THE TARGET POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EVENT OR NEUROLOGICAL SYMPTOMS. A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED OR FRACTURE, ETC), INTRODUCER OR COIL (UNRAVEL, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC) OR MICROCATHETER, AND THE STENT WAS NOT RECAPTURE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 13471872

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER