BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENVOY 6F

    MDR report key: 6607796 · Received June 2, 2017

    Report

    Report Number
    3008264254-2017-00064
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    January 1, 2009
    Report Date
    May 10, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    K093184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN THE PRODUCT AND LOT NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. THE EXACT DATE OF THE PROCEDURE AS WELL AND THE PRODUCT AND LOT NUMBER COULD NOT BE OBTAINED. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. LITERATURE ARTICLE ATTACHED TO FILE: VELAT, G.J., LAWSON, M.F., HOH, B.L., ET AL. (2009). NOVEL APPLICATION OF AN INTERMEDIATE SIZED BRIDGING CATHETER AS AN ADJUNCT TO ANEURYSM COILING IN PATIENTS WITH TORTUOUS VASCULATURE, INTERVENTIONAL NEURORADIOLOGY 15: 448-452, 2009 CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. ARTERIAL DISSECTION IS A KNOWN POSSIBLE ADVERSE EVENT THAT MAY COMPLICATE AN INTRAVASCULAR PROCEDURE, AND IS LISTED IN THE INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. CLINICAL AND PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS, TORTUOSITY, DEVICE SELECTION, AND MANIPULATION OF DEVICES WITHIN THE ARTERY ARE ALL FACTORS THAT MAY CONTRIBUTED TO THE REPORTED EVENT. WITH REVIEW OF THE REPORTED INFORMATION, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE ¿NOVEL APPLICATION OF AN INTERMEDIATE SIZED BRIDGING CATHETER AS AN ADJUNCT TO ANEURYSM COILING IN PATIENTS WITH TORTUOUS VASCULATURE¿ BY G.J.VELAT, M.F. LAWSON, B.L. HOH, J MOCCO, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 15: 448-452, 2009, THE AUTHORS DESCRIBE A PATIENT THAT EXPERIENCED VASOSPASM FOLLOWING PLACEMENT OF A 6 FR ENVOY GUIDE CATHETER (CATALOG/LOT UNK). THE OBSERVATIONAL STUDY ASSESSED THE APPLICATION OF AN INTERMEDIATE SIZED BRIDGING CATHETER IN FOUR PATIENTS WITH TORTUOUS VASCULATURE WHO UNDERWENT SUCCESSFUL COILING OF RUPTURED ANEURYSMS. A (B)(6) WOMAN PRESENTED NEUROLOGICALLY INTACT (HUNT-HESS GRADE I) WITH A SUBARACHNOID HEMORRHAGE FROM A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM (2.4 X 5.5 X 10.3 MM) FILLING VIA A RIGHT DOMINANT A1 ANTERIOR CEREBRAL ARTERY SEGMENT. THE PATIENT WAS TAKEN TO THE ANGIOGRAPHY SUITE FOR COILING. ATTEMPTS AT SELECTIVELY CATHETERIZING THE NECK OF THE ANEURYSM WERE UNSUCCESSFUL DUE TO PROXIMAL COMMON CAROTID ARTERY TORTUOSITY AND FLOW-LIMITING VASOSPASM ENCOUNTERED IN THE DISTAL EXTRACRANIAL AND PROXIMAL INTRACRANIAL SEGMENTS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) IMMEDIATELY FOLLOWING PLACEMENT OF THE 6-FR ENVOY GUIDE CATHETER INTO THE MID-CERVICAL ICA. THE VASOSPASM RESOLVED AFTER WITHDRAWAL OF THE GUIDE CATHETER AND INJECTION OF 10 MG OF INTRA-ARTERIAL VERAPAMIL INTO THE RIGHT ICA OVER 45 MINUTES WITHOUT SIGNIFICANT ALTERATION IN HEMODYNAMIC PARAMETERS. TO AVOID VASOSPASM RECURRENCE, THE GUIDE CATHETER WAS DOCKED AT THE ICA ORIGIN AND A TRIAXIAL CONSTRUCT WAS USED TO SELECTIVELY CATHETERIZE THE TARGET LESION. THE DAC WAS INTRODUCED OVER A PROWLER 14 MICROCATHETER AND SYNCHRO-2 MICROWIRE (BOSTON SCIENTIFIC, (B)(4)). THIS CONSTRUCT WAS THEN ADVANCED IN THE ICA, AND THE DAC WAS PARKED IN THE RIGHT ICA PETRO-CAVERNOUS JUNCTION. A SMALL AMOUNT OF KICKBACK WAS ENCOUNTERED UPON SELECTIVE MICROCATHETERIZATION OF THE ANEURYSM, CAUSING THE INTERMEDIATE SIZED BRIDGING CATHETER TO MIGRATE INTO THE MID-PETROUS SEGMENT OF THE ICA. THE ANEURYSM WAS SUCCESSFULLY EMBOLIZED (95% OBLITERATION), LEAVING ONLY A SMALL NECK REMNANT. NO FURTHER VASOSPASM WAS ENCOUNTERED. NO PROCEDURAL COMPLICATIONS OCCURRED, AND THE PATIENT WAS DISCHARGED HOME NEUROLOGICALLY INTACT ON POST-SAH DAY 15 (POST-COIL DAY 14). NO FURTHER INFORMATION COULD BE OBTAINED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388534 UNKNOWN ENVOY 6F PERCUTANEOUS CATHETER DQY CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention