BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 3170149 · Received June 14, 2013

    Report

    Report Number
    9616099-2013-00366
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING USE OF AN OUTBACK RE-ENTRY CATHETER, THE DISTAL TIP/NOSECONE (WHICH HAS A MARKER BAND) FRACTURED/SEPARATED FROM THE CATHETER SHAFT. THE DISTAL TIP WAS ON THE 014" NON-CORDIS/NON-HYDROPHILIC GUIDEWIRE WHICH WAS USED WITH THE OUTBACK, HOWEVER UPON REMOVAL OF THE GUIDEWIRE TOGETHER WITH THE OUTBACK DEVICE, THE NOSECONE WAS NOT PRESENT. THE SEPARATED PIECE WAS THOUGHT TO BE IN A NON-CRITICAL SMALL BRANCH OF THE DEEP FEMORAL ARTERY AFTER ANGIOGRAPHY. A VASCULAR SURGEON WAS ALSO PRESENT AT THE CASE AND BOTH PHYSICIANS DECIDED THE SEPARATED PIECE WOULD BE TOO DIFFICULT TO RETRIEVE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR FEM-FEM BYPASS. THIS OPTION WAS DISCUSSED PREVIOUSLY WITH THE PATIENT. MULTIPLE ATTEMPTS TO CLARIFY AT WHAT POINT IN THE INTERVENTION THE TIP SEPARATED WERE UNSUCCESSFUL. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS FLUSHED, THEN FLUSHED AGAIN AFTER THIRTY SECONDS AND WAS PREPARED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CANNULA ACTION WAS VERIFIED DURING PREP. THE DEVICE WAS STRAIGHT PRIOR TO LOADING. THE CANNULA WAS NOTED TO BE FULLY RETRACTED INTO THE NOSECONE PRIOR TO INSERTION INTO THE PATIENT. THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) APPROXIMATELY TEN (10) CM. FROM THE OSTIUM OF THE RIGHT COMMON ILIAC (CIA) TO RIGHT EXTERNAL ILIAC ARTERY (EIA). THE APPROACH WAS RETROGRADE. THE ANGLE OF RE-ENTRY WAS ACUTE. THE REPORTER INDICATED THAT ¿SEVERAL PASSES WERE MADE AND WERE VERY DIFFICULT. THE PHYSICIAN WAS UNABLE TO LOCATE THE TRUE LUMEN AND MADE A SUB-INTIMAL SPACE PURPOSELY AND ATTEMPTED TO RE-ENTER THE TRUE LUMEN FROM THE SUB-INTIMAL SPACE. THE PHYSICIAN REACHED THE RE-ENTRY SITE AND DEPRESSED THE HANDLE/SLIDE-RELEASE LEVER TWICE NOTING DIFFICULTY. THE PHYSICIAN THEN DECIDED TO REMOVE THE OUTBACK TO PERFORM BALLOON DILATION AND UPON WITHDRAWAL, THE DISTAL TIP WAS OBSERVED VIA ANGIOGRAPHY IN THE AREA OF THE COMMON FEMORAL ARTERY (CFA). THE GUIDEWIRE BECAME KINKED/BENT AND THE DISTAL TIP BECAME FRAYED/ALMOST SEPARATED. THE PHYSICIAN WAS EXPERIENCED IN THE USE OF THE DEVICE HAVING PERFORMED LESS THAN FIVE (5) CASES. ONE NON-STERILE CATHETER OUTBACK WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE NOSECONE WAS SEPARATED FROM THE CATHETER. NO OTHER DAMAGES WERE OBSERVED IN THE RETURNED DEVICE. RESULTS SHOWED THAT THE CANNULA OUTER SURFACE DID NOT SHOWED EVIDENCE OF ANOMALIES WHICH COULD HAVE INFLUENCED ON THE SEPARATION OF THE RIBBON WIRE. EVEN THOUGH THE RIBBON WIRE WAS ACCIDENTALLY DAMAGED DURING ANALYSIS OWING TO THE SMALL SIZE OF THE COMPONENTS, THE RIBBON WIRE WAS STILL ATTACHED TO THE INNER RING. ALSO, THE SOLDERING POINTS WERE STILL PRESENT ON THE RIBBON WIRE. ACCORDING TO THE OBSERVED CONDITIONS, IN SPITE OF THE SEPARATION OF THE RIBBON WIRE, IT COULD BE CONCLUDED THAT A SMALL SECTION OF THE RIBBON WIRE WAS STILL PRESENT ON THE INNER RING AFTER THE SEPARATION. 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. THE FAILURE CATHETER TIP/DISTAL TIP FRACTURED-SEPARATED/IN PATIENT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED WAS NOT DETERMINED; INNER LINER PRESENT MARKS OF WELDING. THE NEEDLE ACTUATION DIFFICULTY EXPERIENCED WAS LIKELY DUE TO THE SEPARATION OF THE NOSECONE. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (ACUTE ANGLE) AND PROCEDURAL FACTORS (NON-HYDROPHILIC COATATED WIRE AND ¿SEVERAL PASSES¿ ATTEMPTED TO INSERT THE DEVICE MAY HAVE.

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) APPROXIMATELY TEN (10) CM. FROM THE OSTIUM OF THE RIGHT COMMON ILIAC (CIA) TO RIGHT EXTERNAL ILIAC ARTERY (EIA). THE APPROACH WAS RETROGRADE. A NON-CORDIS GUIDEWIRE WAS USED. SEVERAL PASSES WERE MADE AND WERE VERY DIFFICULT. THE PHYSICIAN WAS UNABLE TO LOCATE THE TRUE LUMEN AND MADE A SUB-INTIMAL SPACE PURPOSELY AND ATTEMPTED TO RE-ENTER THE TRUE LUMEN FROM THE SUB-INTIMAL SPACE. THE PHYSICIAN WAS EXPERIENCED IN THE USE OF THE DEVICE HAVING PERFORMED LESS THAN FIVE (5) CASES. THE OUTBACK DEPLOYMENT SYSTEM WAS CHECKED SEVERAL TIMES AND THE CANNULA WAS NOTED TO BE FULLY RETRACTED INTO THE NOSECONE PRIOR TO INSERTION INTO THE PATIENT. THE ANGLE OF RE-ENTRY WAS ACUTE. THE PHYSICIAN REACHED THE RE-ENTRY SITE AND DEPRESSED THE HANDLE/SLIDE-RELEASE LEVER TWICE NOTING DIFFICULTY. THE PHYSICIAN THEN DECIDED TO REMOVE THE OUTBACK TO PERFORM BALLOON DILATION. AFTER WITHDRAWAL, A PROBLEM WAS OBSERVED VIA ANGIOGRAPHY IN THE AREA OF THE COMMON FEMORAL ARTERY (CFA). THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING USE OF AN OUTBACK RE-ENTRY CATHETER, THE DISTAL TIP/NOSECONE (WHICH HAS A MARKER BAND) FRACTURED/SEPARATED FROM THE CATHETER SHAFT WAS ON THE 014" NON-CORDIS/NON-HYDROPHILIC GUIDEWIRE WHICH WAS USED WITH THE OUTBACK. THE GUIDEWIRE WAS RE-USED ONCE PRIOR TO THE REPORTED PRODUCT ISSUE. THE PHYSICIAN FULLY WITHDREW THE OUTBACK CATHETER WITH THE 014" GUIDEWIRE AT THE SAME TIME. WHEN THE OUTBACK AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT/SHEATH, THE NOSECONE WAS NOT PRESENT. THE DISTAL TIP/NOSECONE WAS NOT SUCCESSFULLY RETRIEVED AND REMAINS IN THE PATIENT. THE SEPARATED PIECE WAS THOUGHT TO BE IN A NON-CRITICAL SMALL BRANCH OF THE DEEP FEMORAL ARTERY AFTER ANGIOGRAPHY. A VASCULAR SURGEON WAS ALSO PRESENT AT THE CASE AND BOTH PHYSICIANS DECIDED THE SEPARATED PIECE WOULD BE TOO DIFFICULT TO RETRIEVE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR FEM-FEM BYPASS. THIS OPTION WAS DISCUSSED PREVIOUSLY WITH THE PATIENT. FILMS WERE REPORTED TO BE AVAILABLE. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS FLUSHED, THEN FLUSHED AGAIN AFTER THIRTY SECONDS AND WAS PREPARED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE GUIDEWIRE USED WAS ADVANCED SMOOTHLY WITHOUT RESISTANCE. THE CATHETER WAS STRAIGHT PRIOR TO LOADING AND THE GUIDEWIRE WAS LOADED SUCCESSFULLY. THE CANNULA DID NOT ACTUATE SMOOTHLY. THE GUIDEWIRE BECAME KINKED/BENT AND THE DISTAL TIP BECAME FRAYED/ALMOST SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271936 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15632096

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR