BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART FLEX 5X150 VAS 120CM

    MDR report key: 11023573 · Received December 16, 2020

    Report

    Report Number
    9616099-2020-04131
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 5, 2020
    Report Date
    January 5, 2021
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K130981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE MISSING RESULT AND CONCLUSION CODES ADDED TO H6 NOT INCLUDED IN THE PREVIOUS REPORT IN ERROR. PREVIOUS NARRATIVE: A SMART FLEX 5 X 150 X 120CM SELF-EXPANDING STENT DELIVERY SYSTEM COULD NOT BE RELEASED IN THE PATIENT¿S BODY NORMALLY. THE STENT WAS REMOVED, AND ANOTHER UNKNOWN STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ANALYSIS OF THE PHOTOGRAPHS PROVIDED INDICATE THE BODY SHAFT OF THE UNIT WAS SEPARATED FROM THE HUB AND THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS OPENED IN A STERILE FIELD. A LEFT LOWER LIMB ARTERY STENT IMPLANTATION PROCEDURE WAS BEING PERFORMED AND THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS THE LEFT FEMORAL. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE PROXIMAL PART OF THE DELIVERY SYSTEM WAS STRAIGHTENED AS MUCH AS POSSIBLE AND THE USER KEPT THE HANDLE IN A STABLE POSITION. THE USER GRIPPED THE OUTER SHEATH AND HANDLE WITH ONE HAND AND THE PUSHER TUBE WITH THE OTHER. A SABER BALLOON WITH UNKNOWN SIZE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE AND THREE PICTURES WERE RECEIVED FOR ANALYSIS. A FILE WITH THREE PICTURES OF A SMART FLEX 5X150 VAS 120CM STENT DELIVERY SYSTEM (SDS)-SES WAS RECEIVED FOR VISUAL REVIEW ATTACHED TO THE COMPLAINT (B)(4). PER VISUAL ANALYSIS OF PICTURE 3.JPG, THE PART NUMBER WAS CONFIRMED AS SF05150MV AND LOT NUMBER 223790. PER VISUAL ANALYSIS OF THE PICTURE 1.JPG ATTACHED TO THE COMPLAINT, THE BODY SHAFT OF THE UNIT WAS OBSERVED KINKED AND SEPARATED FROM THE HUB. PER THE VISUAL ANALYSIS OF PICTURE 2.JPG, THE STENT OF THE UNIT CAN BE OBSERVED PARTIALLY DEPLOYED. NO OTHER ANOMALIES WERE OBSERVED. PER PICTURES REVIEW, NEITHER THE CAUSE OF THE REPORTED EVENT NOR THE CAUSE OF THE OBSERVED ANOMALIES COULD BE CONCLUSIVELY DETERMINED BASED ON THE PICTURE¿S VISUAL ANALYSIS SOLE INFORMATION PROVIDED. A NON-STERILE UNIT OF THE SMART FLEX 5X150 VAS 120CM WAS RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE HYPOTUBE OF THE UNIT WAS OBSERVED SEVERELY BENT. THE BODY SHAFT OF THE UNIT WAS RECEIVED SEPARATED FROM THE HUB. THE STENT OF THE UNIT WAS ALREADY HALF DEPLOYED, ALSO A KINK WAS FOUND ON THE BODY SHAFT OF THE UNIT AT 4.0 CM FROM THE HUB. THE VALVE WAS RECEIVED PARTIALLY CLOSED. DRIED BLOOD RESIDUES WERE OBSERVED. NO OTHER ANOMALIES FOUND. DIMENSIONAL ANALYSIS TO MEASURE THE USABLE LENGTH AND OUTER SHEATH LENGTH OF THE UNIT WAS NOT PERFORMED DUE TO THE SEPARATED CONDITION OF THE OUTER MEMBER OF THE UNIT THE WAY IT WAS RECEIVED. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE SEVERE DAMAGE CONDITION OF THE UNIT AS RECEIVED. PER MICROSCOPIC ANALYSIS, THE SMART FLEX BODY SHAFT SEPARATED AREA WAS OBSERVED UNDER THE VISION SYSTEM AND THE SEPARATED SECTION OF THE UNIT PRESENTED ELONGATIONS AND FRAYED EDGES. THESE CHARACTERISTICS ARE A CLEAR EVIDENCE THAT AN APPLICATION OF A TENSION FORCE WAS INDUCED ON THE PRODUCT AND CAUSED THE SEPARATION. ALSO, THE KINK FOUND ON THE BODY SHAFT OF THE UNIT ON THE OUTER MEMBER WAS MAGNIFIED OBSERVED. NO OTHER ISSUES WERE NOTED DURING THE MICROSCOPIC ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 223790 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-DEPLOYMENT DIFFICULTY ¿ UNABLE¿, ¿STENT DELIVERY SYSTEM (SDS)-SES- DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT¿, AS WELL AS ¿LUER HUB (INNER SHAFT)- [GUIDE WIRE LUMEN- SEPARATED¿ WERE CONFIRMED DUE TO THE SEVERE DAMAGED AND SEPARATED CONDITION OF THE UNIT THE WAY IT WAS RETURNED FOR ANALYSIS. HOWEVER, THE EXACT CAUSE OF THE SEVERE DAMAGE AND SEPARATED CONDITION OF THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE PRODUCT ANALYSIS. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENTS BASED ON THE INFORMATION AVAILABLE. HOWEVER, IT IS PROBABLE THAT PROCEDURAL AND OR HANDLING FACTORS SUCH AS THE USER¿S INTERACTION WITH THE DEVICE AND VESSEL CHARACTERISTICS (ALTHOUGH UNKNOWN) MAY HAVE LED TO THE REPORTED EVENTS. ACCORDING TO THE INSTRUCTIONS FOR USE ¿ENSURE THAT THE TUOHY BORST VALVE, CONNECTING THE INNER SHAFT AND OUTER SHEATH, IS LOCKED BY ROTATING THE PROXIMAL VALVE END IN A CLOCKWISE DIRECTION TO PREVENT PREMATURE STENT DEPLOYMENT. ADVANCE THE DEVICE OVER THE GUIDEWIRE TO THE LESION SITE. NOTE: IF RESISTANCE IS MET DURING DELIVERY SYSTEM INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN, AND ANOTHER SYSTEM SHOULD BE USED. NEITHER THE PHR REVIEW, IMAGE REVIEWS NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 0

    A SMART FLEX 5 X 150 X 120CM SELF-EXPANDING STENT DELIVERY SYSTEM COULD NOT BE RELEASED IN THE PATIENT¿S BODY NORMALLY. THE STENT WAS REMOVED, AND ANOTHER UNKNOWN STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ANALYSIS OF THE PHOTOGRAPHS PROVIDED INDICATE THE BODY SHAFT OF THE UNIT WAS SEPARATED FROM THE HUB AND THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS OPENED IN A STERILE FIELD. A LEFT LOWER LIMB ARTERY STENT IMPLANTATION PROCEDURE WAS BEING PERFORMED AND THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS THE LEFT FEMORAL. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE PROXIMAL PART OF THE DELIVERY SYSTEM WAS STRAIGHTENED AS MUCH AS POSSIBLE AND THE USER KEPT THE HANDLE IN A STABLE POSITION. THE USER GRIPPED THE OUTER SHEATH AND HANDLE WITH ONE HAND AND THE PUSHER TUBE WITH THE OTHER. A SABER BALLOON WITH UNKNOWN SIZE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 223790 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE AND THREE PICTURES WERE RECEIVED FOR ANALYSIS. A FILE WITH THREE PICTURES OF A SMART FLEX 5X150 VAS 120CM STENT DELIVERY SYSTEM (SDS)-SES WAS RECEIVED FOR VISUAL REVIEW ATTACHED TO THE COMPLAINT (B)(4). PER VISUAL ANALYSIS OF PICTURE 3.JPG, THE PART NUMBER WAS CONFIRMED AS SF05150MV AND LOT NUMBER 223790. PER VISUAL ANALYSIS OF THE PICTURE 1.JPG ATTACHED TO THE COMPLAINT, THE BODY SHAFT OF THE UNIT WAS OBSERVED KINKED AND SEPARATED FROM THE HUB. PER THE VISUAL ANALYSIS OF PICTURE 2.JPG, THE STENT OF THE UNIT CAN BE OBSERVED PARTIALLY DEPLOYED. NO OTHER ANOMALIES WERE OBSERVED. PER PICTURES REVIEW, NEITHER THE CAUSE OF THE REPORTED EVENT NOR THE CAUSE OF THE OBSERVED ANOMALIES COULD BE CONCLUSIVELY DETERMINED BASED ON THE PICTURE¿S VISUAL ANALYSIS SOLE INFORMATION PROVIDED. A NON-STERILE UNIT OF THE SMART FLEX 5X150 VAS 120CM WAS RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE HYPOTUBE OF THE UNIT WAS OBSERVED SEVERELY BENT. THE BODY SHAFT OF THE UNIT WAS RECEIVED SEPARATED FROM THE HUB. THE STENT OF THE UNIT WAS ALREADY HALF DEPLOYED, ALSO A KINK WAS FOUND ON THE BODY SHAFT OF THE UNIT AT 4.0 CM FROM THE HUB. THE VALVE WAS RECEIVED PARTIALLY CLOSED. DRIED BLOOD RESIDUES WERE OBSERVED. NO OTHER ANOMALIES FOUND. DIMENSIONAL ANALYSIS TO MEASURE THE USABLE LENGTH AND OUTER SHEATH LENGTH OF THE UNIT WAS NOT PERFORMED DUE TO THE SEPARATED CONDITION OF THE OUTER MEMBER OF THE UNIT THE WAY IT WAS RECEIVED. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE SEVERE DAMAGE CONDITION OF THE UNIT AS RECEIVED. PER MICROSCOPIC ANALYSIS, THE SMART FLEX BODY SHAFT SEPARATED AREA WAS OBSERVED UNDER THE VISION SYSTEM AND THE SEPARATED SECTION OF THE UNIT PRESENTED ELONGATIONS AND FRAYED EDGES. THESE CHARACTERISTICS ARE A CLEAR EVIDENCE THAT AN APPLICATION OF A TENSION FORCE WAS INDUCED ON THE PRODUCT AND CAUSED THE SEPARATION. ALSO, THE KINK FOUND ON THE BODY SHAFT OF THE UNIT ON THE OUTER MEMBER WAS MAGNIFIED OBSERVED. NO OTHER ISSUES WERE NOTED DURING THE MICROSCOPIC ANALYSIS. THE REPORTED ¿STENT DELIVERY SYSTEM (SDS)-SES-DEPLOYMENT DIFFICULTY ¿ UNABLE¿, ¿STENT DELIVERY SYSTEM (SDS)-SES- DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT¿, AS WELL AS ¿LUER HUB (INNER SHAFT)- [GUIDE WIRE LUMEN- SEPARATED¿ WERE CONFIRMED DUE TO THE SEVERE DAMAGED AND SEPARATED CONDITION OF THE UNIT THE WAY IT WAS RETURNED FOR ANALYSIS. HOWEVER, THE EXACT CAUSE OF THE SEVERE DAMAGE AND SEPARATED CONDITION OF THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE PRODUCT ANALYSIS. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENTS BASED ON THE INFORMATION AVAILABLE. HOWEVER, IT IS PROBABLE THAT PROCEDURAL AND OR HANDLING FACTORS SUCH AS THE USER¿S INTERACTION WITH THE DEVICE AND VESSEL CHARACTERISTICS (ALTHOUGH UNKNOWN) MAY HAVE LED TO THE REPORTED EVENTS. ACCORDING TO THE INSTRUCTIONS FOR USE ¿ENSURE THAT THE TUOHY BORST VALVE, CONNECTING THE INNER SHAFT AND OUTER SHEATH, IS LOCKED BY ROTATING THE PROXIMAL VALVE END IN A CLOCKWISE DIRECTION TO PREVENT PREMATURE STENT DEPLOYMENT. ADVANCE THE DEVICE OVER THE GUIDEWIRE TO THE LESION SITE. NOTE: IF RESISTANCE IS MET DURING DELIVERY SYSTEM INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN, AND ANOTHER SYSTEM SHOULD BE USED. NEITHER THE PHR REVIEW, IMAGE REVIEWS NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, A FILE WITH THREE PICTURES OF A SMART FLEX 5X150 VAS 120CM STENT DELIVERY SYSTEM (SDS)-SES WAS RECEIVED FOR VISUAL REVIEW ATTACHED TO THE COMPLAINT (B)(4). PER VISUAL ANALYSIS OF PICTURE 3.JPG, THE PART NUMBER WAS CONFIRMED AS SF05150MV AND LOT NUMBER 223790. PER VISUAL ANALYSIS OF THE PICTURE 1.JPG, THE BODY SHAFT OF THE UNIT WAS OBSERVED KINKED AND SEPARATED FROM THE HUB. PER THE VISUAL ANALYSIS OF PICTURE 2.JPG, THE STENT OF THE UNIT CAN BE OBSERVED PARTIALLY DEPLOYED. NO OTHER ANOMALIES WERE OBSERVED. THE DEVICE WAS RETURNED BUT 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.

    Description of Event or Problem · 1

    AS REPORTED, A 5 X 150 X 120CM SMART FLEX SELF-EXPANDING STENT DELIVERY SYSTEM COULD NOT BE RELEASED IN THE PATIENT¿S BODY NORMALLY. THE STENT WAS REMOVED AND ANOTHER UNKNOWN STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. ANALYSIS OF THE PHOTOGRAPHS PROVIDED INDICATE THE BODY SHAFT OF THE UNIT WAS SEPARATED FROM THE HUB AND THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS OPENED IN A STERILE FIELD. A LEFT LOWER LIMB ARTERY STENT IMPLANTATION PROCEDURE WAS BEING PERFORMED AND THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS THE LEFT FEMORAL. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE PROXIMAL PART OF THE DELIVERY SYSTEM WAS STRAIGHTENED AS MUCH AS POSSIBLE AND THE USER KEPT THE HANDLE IN A STABLE POSITION. THE USER GRIPPED THE OUTER SHEATH AND HANDLE WITH ONE HAND AND THE PUSHER TUBE WITH THE OTHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. ADDITIONAL PATIENT AND PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. A SABER BALLOON WITH UNKNOWN SIZE WAS USED. THE DEVICE WILL BE RETURNED FOR EVALUATION. PRODUCT IMAGES ARE AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485200 SMART FLEX 5X150 VAS 120CM CATHETER, BILIARY, DIAGNOSTIC FGE CARDINAL HEALTH MEXICO SF05150MV 223790

    Patients

    Seq Age Sex Outcome Treatment
    1 SABER BALLOON