BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART FLEX 5X120 BIL, 120CM

    MDR report key: 12688685 · Received October 25, 2021

    Report

    Report Number
    3005089785-2021-00001
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 9, 2021
    Manufacturer
    CORDIS CASHEL
    Product Code
    FGE
    PMA / PMN Number
    K130981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED IN TWO PIECES AND THE ENGINEERING REPORT IS PENDING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(4).

    Additional Manufacturer Narrative · 0

    PLEASE NOTE UPDATE TO THE UDI# IN SECTION D4. ADDITIONAL H6 DEVICE CODE: SEPARATION, 2906. THE DEPLOYMENT WIRE THAT A 5X120 BIL, 120CM SMART FLEX STENT WAS ATTACHED TO GOT HUNG UP ON THE DISTAL END OF THE STENT AND DID NOT WANT TO RELEASE. THE PHYSICIAN TRIED SOME DIFFERENT TECHNIQUES TO REMOVE IT AND AFTER MUCH TIME WERE FINALLY ABLE TO DISCONNECT IT FROM THE STENT AND REMOVE THE DEPLOYMENT DEVICE. THE STENT WAS DEPLOYED AT THE INTENDED SITE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ANALYSIS OF THE RETURNED DEVICE INDICATED THE METALLIC PUSH ROD WAS COMPLETELY SEPARATED FROM THE HUB. THE INTENDED PROCEDURE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING. THE LESION WAS 5MM IN DIAMETER WITH MODERATE CALCIFICATION AND NO VESSEL TORTUOSITY. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. A 6F NON-CORDIS SHEATH WAS USED IN THE PROCEDURE. THE STENT DELIVERY SYSTEM PASSED THROUGH ACUTE BENDS. THE PROXIMAL PART OF THE DELIVERY SYSTEM WAS STRAIGHTENED AS MUCH AS POSSIBLE, AND THE HANDLE WAS KEPT IN A STABLE POSITION. THE TUOHY BORST VALVE ON THE HANDLE WAS LOOSENED TO ALLOW FREE MOVEMENT OF THE PUSHER TUBE. THE USER GRIPPED THE OUTER SHEATH AND HANDLE WITH ONE HAND AND THE PUSHER TUBE WITH THE OTHER. THE USER ALSO MOVED THE OUTER SHEATH PROXIMALLY RELATIVE TO THE PUSHER TUBE WHILE HOLDING THE PUSHER TUBE IN A FIXED POSITION. RESISTANCE WAS FELT WHILE TRYING TO RETRACT THE DEPLOYMENT HANDLE. THE DEPLOYMENT WIRE WAS FINALLY LOOSENED FROM THE STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL ANALYSIS: A NON-STERILE UNIT OF PRODUCT ¿SMART FLEX 5X120 BIL, 120CM¿ WAS RECEIVED COILED INSIDE OF A CLEAR PLASTIC BAG. PART WAS UNPACKED AND LAID ON A TRAY TO PERFORM THE PRODUCT EVALUATION. THE UNIT WAS THOROUGHLY INSPECTED OBSERVING THE FOLLOWING CONDITIONS: THE UNIT IS FULLY DEPLOYED, AND THE STENT WAS NOT RETURNED FOR ANALYSIS; THE METALLIC PUSH ROD IS COMPLETELY SEPARATED FROM THE HUB; THE DEVICE IS BLOOD SATURATED; A KINKED/BENT CONDITION IS LOCATED AT 110 CM FROM THE DISTAL TIP; THE HEMOSTASIS VALVE WAS RECEIVED CLOSE TIGHTEN. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. DIMENSIONAL ANALYSIS WAS PERFORMED TO VERIFY THE CORRECT OUTER DIAMETER (OD) OF THE CROSSING PROFILE. MEASUREMENTS WERE TAKEN AT THREE DIFFERENT PLACES AND RESULTS WERE FOUND WITHIN SPECIFICATION. FUNCTIONAL TEST: FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO CONDITION AS OF THE DEVICE, AS RECEIVED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 266309 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿STENT DELIVERY SYSTEM (SDS)-SES ~ - WITHDRAWAL DIFFICULTY - SNAGGED/CAUGHT ON STENT ¿COULD NOT BE PROPERLY EVALUATED DUE TO THE CONDITIONS OF THE RETURNED UNIT. THE REPORTED ¿STENT DELIVERY SYSTEM (SDS)-SES ~ SEPARATED - IN PATIENT¿ WAS CONFIRMED. A METALLIC PUSH ROD SEPARATION AND KINKED/BENT BODY/SHAFT WERE OBSERVED. THE DIMENSIONAL ANALYSIS RESULTS OF THE PART WERE FOUND WITHIN SPECIFICATION. EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. HOWEVER, IT IS REASONABLE TO CONSIDER THAT PROCEDURAL FACTORS SUCH AS VESSEL CHARACTERISTICS (MODERATE CALCIFICATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. ADDITIONALLY, HANDLINGS FACTORS SUCH AS THE USER¿S INTERACTION WITH THE DEVICE DURING USE AS STATED BY THE END USER ¿RESISTANCE WAS FELT WHILE TRYING TO RETRACT THE DEPLOYMENT HANDLE¿ MAY HAD LED TO THE REPORTED SEPARATION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) ¿ADVANCE THE DEVICE OVER THE GUIDEWIRE AND THROUGH THE INTRODUCER TO THE TARGET SITE. IF RESISTANCE IS MET DURING DELIVERY SYSTEM INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM USED. IF RESISTANCE IS FELT DURING RETRACTION OF THE OUTER SHEATH DO NOT FORCE DEPLOYMENT. CAREFULLY WITHDRAW THE STENT SYSTEM WITHOUT DEPLOYING THE STENT.¿ NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED CONDITIONS COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    THE DEPLOYMENT WIRE THAT A 5X120 BIL, 120CM SMART FLEX STENT WAS ATTACHED TO GOT HUNG UP ON THE DISTAL END OF THE STENT AND DID NOT WANT TO RELEASE. THE PHYSICIAN TRIED SOME DIFFERENT TECHNIQUES TO REMOVE IT AND AFTER MUCH TIME WERE FINALLY ABLE TO DISCONNECT IT FROM THE STENT AND REMOVE THE DEPLOYMENT DEVICE. THE STENT WAS DEPLOYED AT THE INTENDED SITE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING. THE LESION WAS 5MM IN DIAMETER WITH MODERATE CALCIFICATION AND NO VESSEL TORTUOSITY. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. A 6F NON-CORDIS SHEATH WAS USED IN THE PROCEDURE. THE STENT DELIVERY SYSTEM PASSED THROUGH ACUTE BENDS. THE PROXIMAL PART OF THE DELIVERY SYSTEM WAS STRAIGHTENED AS MUCH AS POSSIBLE, AND THE HANDLE WAS KEPT IN A STABLE POSITION. THE TUOHY BORST VALVE ON THE HANDLE WAS LOOSENED TO ALLOW FREE MOVEMENT OF THE PUSHER TUBE. THE USER GRIPPED THE OUTER SHEATH AND HANDLE WITH ONE HAND AND THE PUSHER TUBE WITH THE OTHER. THE USER ALSO MOVED THE OUTER SHEATH PROXIMALLY RELATIVE TO THE PUSHER TUBE WHILE HOLDING THE PUSHER TUBE IN A FIXED POSITION. RESISTANCE WAS FELT WHILE TRYING TO RETRACT THE DEPLOYMENT HANDLE. THE DEPLOYMENT WIRE WAS FINALLY LOOSENED FROM THE STENT. ADDITIONAL PATIENT INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592372 SMART FLEX 5X120 BIL, 120CM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CASHEL N/A 266309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 6F TERUMO SHEATH