BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1830339 · Received September 10, 2010

    Report

    Report Number
    1058196-2010-00251
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 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

    CORRECTED DATA: PLEASE NOTE THAT THE ANALYSIS FOR THIS PRODUCT WAS COMPLETED ON (B)(4) 2010, BUT WAS ACCIDENTALLY NOT INCLUDED WITH THE INITIAL MEDWATCH REPORT. THE INITIAL REPORT INDICATED THAT WHEN THE ENTERPRISE VRD SYSTEM ((B)(4)) WAS INSERTED INTO THE PROWLER SELECT PLUS 45 MICROCATHETER (MC) LARGE FRICTION WAS FELT. THE VRD AND (MC) WERE REMOVED FROM THE PATIENT AS A UNIT AND CHANGED TO ANOTHER VRD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. HOWEVER, THE RETURNED MC WAS RECEIVED WITH THE HUB DETACHED. WITH FOLLOW-UP INVESTIGATION IT WAS REPORTED THAT THE PHYSICIAN MIGHT HAVE CUT THE MC DURING HIS INSPECTION AFTER THE PROCEDURE/OUTSIDE OF THE PATIENT'S BODY. ALTHOUGH THE PHYSICIAN DID NOT CONFIRM HE CUT OFF THE MC, IT WAS CONFIRMED THAT THE SEPARATION DID NOT OCCUR DURING THE PROCEDURE/WITHIN THE PATIENT. THE PROCEDURE WAS COIL EMBOLIZATION FOR ANEURYSM IN BASILAR ARTERY TIP IN A (B)(6) FEMALE. THE ANEURYSM WAS LOCATED IN THE BIFURCATION AREA AND HAD A NECK OF 13MM. NO INFORMATION ABOUT VESSEL'S CHARACTERISTICS WAS PROVIDED. AFTER A VRD WAS PLACED AT THE TARGET LESION AN ATTEMPT TO PLACE A SECOND ENTERPRISE VRD AT THE TARGET VESSEL VIA A Y-STENT TECHNIQUE WAS MADE. A CONSTANT AND DEDICATED SALINE FLUSH WAS ATTACHED AND MAINTAINED IN THE MC. DURING INSERTION, CONSTANT FLUOROSCOPY WAS UTILIZED. THERE WERE NO CONTRIBUTING FACTORS IDENTIFIED BY THE REPORTER. AFTER THE EVENT, ALL THE DEVICES WERE REMOVED AND EXCHANGED TO THE OTHER PRODUCTS. THERE WAS NO INFORMATION ABOUT THE PRODUCTS. OTHER THAN THE DAMAGE TO THE MICROCATHETER, NO DAMAGES WERE NOTICED ON THE STENT, DELIVERY SYSTEM OR MICROCATHETER AFTER THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. (B)(6) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF ENTERPRISE LOT (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) AND WAS DETERMINED TO BE ACCEPTABLE. A NON STERILE PROWLER SELECT PLUS MC WAS RECEIVED ACCOMPANIED OF AN ENTERPRISE BOTH COILED INSIDE OF A PLASTIC BAG. THE ENTERPRISE STENT WAS NOT RECEIVED FOR ANALYSIS, ONLY THE DELIVERY WIRE AND INTRODUCER TUBE WHICH WERE OUT OF MC WERE RECEIVED. THE MC WAS RECEIVED SEPARATED IN TWO PARTS; THE FIRST PART MEASURED 8.8CM INCLUDING THE HUB AND PRESENTED A KINK AT 4.5CM FROM THE HUB, THE SECOND PART MEASURED 148.1CM AND PRESENTED NO DAMAGES. THE ID OF THE MC WAS MEASURED AND IS WITHIN SPECIFICATION. THE HUB WAS INSPECTED UNDER MICROSCOPE AND NO ANOMALIES WERE NOTED. THE CUT SECTION WAS INSPECTED UNDER MICROSCOPE AND IT APPEARS TO HAVE BEEN CUT USING SOME KIND OF BLADE. AN ATTEMPT TO INSERT THE RECEIVED ENTERPRISE INTO THE FIRST SECTION OF THE MC WAS MADE; BUT IT WAS STUCK DUE TO THE KINK NOTED NEAR TO THE HUB; THEN IT WAS REMOVED FROM THE FIRST SECTION TO BE INSERTED IN THE SECOND SECTION OF THE MC WHERE SOME FRICTION WAS EXPERIENCED DUE TO THE RESIDUES OF BLOOD THAT WERE INSIDE OF THE DEVICE. THE ENTERPRISE ONLY ADVANCED 79.5CM AND AT THIS POINT IT GOT STUCK. THE MC CUT AT 80.5CM FROM THE DISTAL END AND RESIDUES OF BLOOD CAME OUT, AFTER THAT THE MICROCATHETER WAS SPLIT OFF AND A BLOCKAGE OF BLOOD WAS FOUND AT 79.5CM WHERE THE ENTERPRISE WAS STUCK. THE ENTERPRISE DELIVERY WIRE WAS INSPECTED UNDER A MICROSCOPE AND NO ANOMALIES WERE FOUND. THE DELIVERY WIRE WAS INTRODUCED THROUGH OF THE PART OF THE MC THAT PRESENTED NO DAMAGES AND WAS ABLE TO GO THROUGH WITHOUT ANY RESISTANCE OR FRICTION BETWEEN BOTH DEVICES. ADDITIONALLY THE RETURNED ENTERPRISE DELIVERY WIRE WAS INTRODUCED THROUGH A LAB SAMPLE MC AND NO ANOMALIES WERE FOUND. THE REPORTED RESISTANCE FRICTION WITH INSERTION OF THE RETURNED ENTERPRISE DELIVERY WIRE THROUGH THE RETURNED PROWLER SELECT PLUS MC WAS CONFIRMED. THE CAUSE OF THE FAILURE WAS THE RESIDUES OF BLOOD THAT BLOCKED THE INNER LUMEN AND PREVENTED INTRODUCTION OF THE ENTERPRISE. IN ADDITION THE KINK FOUND NEAR TO THE HUB PREVENTION INTRODUCTION. THE CAUSE OF THE KINKS/BEND AND THE CUT SECTION NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INFORMATION THAT THE FIRST VRD WENT THROUGH THE SAME MC PRIOR TO THE EVENT AND THE REPORT THAT THE MC MAY HAVE BEEN CUT BY THE USER AFTER REMOVAL IT APPEARS THAT PROCEDURAL AND HANDLING FACTORS CONTRIBUTED TO THE EVENT. ALTHOUGH IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AS OUTLINED IN THE INSTRUCTIONS FOR USE, BASED ON THE FINDINGS OF RESIDUES OF BLOOD OCCLUDING THE RETURNED DEVICE, IT APPEARS THAT THIS FACTOR MAY HAVE CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE ANALYSIS OF THE DEVICES, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF FAILURES FROM LEAVING THE MANUFACTURING FACILITY. THEREFORE, NO CORRECTIVE ACTIONS 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 1058196-2010-00251 AND 1058196-2010-00250.

    Additional Manufacturer Narrative · 1

    DURING INSERTION, CONSTANT FLUOROSCOPY WAS UTILIZED. THERE WERE NO CONTRIBUTING FACTORS TO THE EVENT. AFTER THE EVENT, ALL THE DEVICES WERE REMOVED AND EXCHANGED TO THE OTHER PRODUCTS. THERE WAS NO INFORMATION ABOUT THE PRODUCT. OTHER THAN THE DAMAGE TO THE MICROCATHETER, NO DAMAGES WERE NOTICED ON THE STENT, DELIVERY SYSTEM OR MICROCATHETER AFTER THE EVENT. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00251 & 1058196-2010-00250.

    Description of Event or Problem · 1

    THE INITIAL REPORT INDICATED THAT WHEN THE VRD (B)(4) WAS INSERTED INTO THE MICROCATHETER (PROWLER SELECT PLUS 45, DETAIL UNKNOWN), LARGE FRICTION WAS FELT. THE VRD AND MICROCATHETER WERE REMOVED FROM THE PATIENT AS UNIT, AND CHANGED TO THE OTHER VRD AND PRODUCTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. ADDITIONALLY, THE MICROCATHETER WAS RECEIVED WITH THE HUB DETACHED. INFORMATION RECEIVED INDICATED THAT THOUGH THE PHYSICIAN DID NOT CONFIRM HE CUT OFF THE (MC) MICROCATHETER, IT WAS CONFIRMED THAT THE SEPARATION DID NOT OCCUR DURING THE PROCEDURE/WITHIN THE PATIENT. THE PHYSICIAN MIGHT CUT THE MC DURING HIS INSPECTION AFTER THE PROCEDURE/OUTSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS COIL EMBOLIZATION FOR ANEURYSM IN BASILAR ARTERY TIP. THE ANEURYSM WAS LOCATED IN THE BIFURCATION AREA. NO INFORMATION ABOUT VESSEL'S CHARACTERISTICS WAS PROVIDED. AFTER A VRD WAS PLACED IN THE TARGET ANEURYSM, THE VRD (COMPLAINT PRODUCT) WAS TRIED TO BE PLACED IN THE TARGET VESSEL BY Y-STENT TECHNIQUE. THE NECK SIZE WAS 13MM. A CONSTANT AND DEDICATED SALINE FLUSH WAS ATTACHED AND MAINTAINED IN THE MICROCATHETER.

    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. 13471874

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR UNKNOWN PROWLER SELECT PLUS.