BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OUTBACK

    MDR report key: 3030153 · Received April 2, 2013

    Report

    Report Number
    9616099-2013-00199
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    November 15, 2009
    Report Date
    March 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THIS PRODUCT IS DESIGNED FOR USE BY PHYSICIANS TRAINED IN AND FAMILIAR WITH PERIPHERAL PERCUTANEOUS INTERVENTIONAL TECHNIQUES. POSSIBLE COMPLICATIONS MAY INCLUDE VESSEL DISSECTION, PERFORATION, OR INJURY. TRACKING THE OUTBACK THROUGH AN ACUTE VESSEL ANGLE, SUCH AS THE AORTO-ILIAC BIFURCATION, MAY CONTRIBUTE TO THE EVENT REPORTED. DIFFICULTY CROSSING A LESION OR AN ANATOMICAL STRUCTURE IS A KNOWN PROCEDURAL OCCURRENCE. THE CONSEQUENCES OF THESE TYPES OF DIFFICULTIES OCCURRING DURING CLINICAL USE OF THE DEVICE ARE USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. WITHOUT A LOT NUMBERS TO CONDUCT A DHR REVIEW AND THE PRODUCTS TO CONDUCT AN EVALUATION, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00198 AND 9616099-2013-00199.

    Description of Event or Problem · 1

    BESHORNER ET AL RECANALIZATION OF CHRONIC OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY USING THE OUTBACK TM RE-ENTRY CATHETER: A SINGLE CENTRE EXPERIENCE; CATHETERIZATION AND CARDIOVASCULAR INTERVENTION 74: 934-938; REPORT A CASE WHERE 1 PATIENT DIED OF MYOCARDIAL INFARCTION AFTER DELAYED FEMORAL BLEEDING POSSIBLY DUE TO EXTENSIVE RECANALISATION ATTEMPTS. RECANALIZATION OF THE ARTERIAL OCCLUSION WAS NOT SUCCESSFUL IN 6 CASES. IN ONE CASE, THE OUTBACK CATHETER COULD NOT PASS THE CROSS OVER SHEATH DUE TO EXTREME KINKING OF THE ILIAC VESSELS. IN ANOTHER CASE, RE-ENTRY COULD BE ESTABLISHED, BUT AFTER PLACING THE 14-INCH WIRE THE RETRACTION MECHANISM OF THE CANNULA NEEDLE FAILED. THE SYSTEM HAD TO BE RETRIEVED WITH THE NEEDLE PARTIALLY EXTENDED. BECAUSE OF HEAVY FRICTION, THE WIRE HAD TO BE REMOVED TOGETHER WITH THE OUTBACK CATHETER AND THE SUBINTIMAL CHANNEL WAS LOST SUBSEQUENTLY. THE OUTBACK CATHETER IS A FLUOROSCOPICALLY CONTROLLED RE-ENTRY SYSTEM, SINGLE LUMEN 7F CATHETER THAT CAN BE TRACKED OVER A 0.014-INCH EXTRA-SUPPORT GUIDE WIRE IN CHRONIC TOTAL OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. BETWEEN MARCH 2007 AND AUGUST 2008, 65 LEGS IN 61 PATIENTS WITH CHRONIC OCCLUSION OF THE SFA AND PROXIMAL POPLITEAL ARTERY WERE TREATED. THERE WERE 20 FEMALES AND 41 MALES, MEAN AGE WAS 73 (RANGE 49-98 YEARS). ALL OF THEM WERE REFERRED BECAUSE OF CHRONIC OCCLUSION OF THE SFA AND PROXIMAL POPLITEAL ARTERY. ALL PATIENTS HAD RECENT FEMORAL VESSEL IMAGING BY DUPLEX ULTRASOUND, CT ANGIOGRAPHY OR MR ANGIOGRAPHY. ARTERIAL ACCESS WAS ACHIEVED USING EITHER A RETROGRADE TRANSFEMORAL APPROACH (6F OR 7F BALKIN CROSS OVER SHEATH). AFTER BASELINE ANGIOGRAPHY, INTRALUMINAL OR SUBINTIMAL PASSAGE OF THE LESION WAS ATTEMPTED USING A 0.035 INCH HYDROPHILIC COATED J-CURVED GUIDEWIRE (GLIDEWIRE, TERUMO CORP). THE OUTBACK SYSTEM WAS ONLY USED, IF THE TRUE LUMEN COULD NOT BE ENTERED AFTER SUBINTIMAL PASSAGE AND MULTIPLE CONVENTIONAL RE-ENTRY MANEUVERS USING 5F DIAGNOSTIC CATHETERS WITH ANGLED TIP (VERTEBRAL OR JUDKINS CONFIGURATION) REMAINED UNSUCCESSFUL AFTER AT LEAST 15 MINUTES. IN THAT CASE, THE 0.035-INCH GUIDE WIRE WAS EXCHANGED FOR A 0.014 INCH EXTRA-SUPPORT GUIDE WIRE AND THE OUTBACK CATHETER WAS DELIVERED TO THE SUBINTIMAL SPACE DISTAL TO THE OCCLUDED SEGMENT. IF THE CATHETER COULD NOT BE ADVANCED DUE TO FRICTION IN HEAVY CALCIFIED SEGMENTS, THE SUBINTIMAL SPACE WAS PRE-DILATATED USING 3- TO 5-MM BALLOON CATHETERS. RECANALIZATION OF THE ARTERIAL OCCLUSION WAS SUCCESSFUL IN 57 OF 65 TREATED LESIONS (88%). IN SIX CASES, NO RE-ENTRY COULD BE ESTABLISHED. FIVE OF THESE PATIENTS WERE TREATED SUCCESSFULLY BY TRANSPOPLITEAL ACCESS, ONE PATIENT WAS TREATED WITH CONSERVATIVE MEDICAL THERAPY. IN ONE CASE, THE OUTBACK CATHETER COULD NOT PASS THE CROSS-OVER SHEATH DUE TO EXTREME KINKING OF THE ILIAC VESSELS. THIS LESION WAS ALSO SUCCESSFULLY TREATED BY TRANS-POPLITEAL ACCESS. IN ANOTHER CASE, RE-ENTRY COULD BE ESTABLISHED, BUT AFTER PLACING THE 14-INCH WIRE THE RETRACTION MECHANISM OF THE CANNULA NEEDLE FAILED. THUS, THE SYSTEM HAD TO BE RETRIEVED WITH THE NEEDLE PARTIALLY EXTENDED. BECAUSE OF HEAVY FRICTION, THE WIRE HAD TO BE REMOVED TOGETHER WITH THE OUTBACK CATHETER AND THE SUBINTIMAL CHANNEL WAS LOST SUBSEQUENTLY. THIS LESION WAS TREATED SUCCESSFULLY 3 DAYS AFTER IN A SECOND PROCEDURE USING THE OUTBACK SYSTEM AGAIN. ONE PATIENT DIED OF MYOCARDIAL INFARCTION AFTER DELAYED FEMORAL BLEEDING 12 HR AFTER THE RECANALIZATION PROCEDURE. THE BLEEDING OCCURRED AT THE TREATED LEG POSSIBLY DUE TO EARLIER EXTENSIVE PUNCTURE ATTEMPTS WITH THE OUTBACKTM NEEDLE. THERE WERE NO MORE PROCEDURE RELATED COMPLICATIONS SUCH AS PERIPHERAL EMBOLIZATION OR VASCULAR PERFORATION WITH FORMATION OF PSEUDOANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134064 UNKNOWN OUTBACK CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6F OR 7F BALKIN SHEATH, TERUMO 0.035 GUIDEWIRE