BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP

    MDR report key: 19709710 · Received July 10, 2024

    Report

    Report Number
    9616099-2024-00235
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 14, 2024
    Report Date
    November 6, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE LUER HUB OF THE 6F .070IN (B)(6) RIGHT (JR) 4 100CM VISTA BRITE TIP GUIDING CATHETER WAS OOZING BLOOD ALL OVER AND COULD NOT WORK PROPERLY. THE PROCEDURE WAS COMPLETED BY CHANGING TO A NEW CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. A CONTRALATERAL APPROACH WAS NOT USED. THE VESSEL CHARACTERISTICS AT THE TARGET SITE WERE AS FOLLOWS: NO CALCIFICATION, NO TORTUOSITY, 85% STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. AT THE ACCESS SITE, THERE WAS NO CALCIFICATION, NO TORTUOSITY, NO STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB, BUT IT WAS TORQUED. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES TO THE DEVICE PACKAGING PRIOR TO USE. THE DEVICE WILL BE RETURNED FOR EVALUATION. A NON-STERILE ¿6F .070 JR 4 100CM¿ UNIT WAS RECEIVED FOR ANALYSIS. THE DEVICE WAS INSPECTED OBSERVING THAT MULTIPLE KINKS/COMPRESSION WERE OBSERVED ON THE RETURNED UNIT AND LOCATED 19, 59, 76 AND 77 CM APART FROM THE DISTAL END. INNER DIAMETER (ID) AND OUTER DIAMETER (OD) MEASUREMENTS WERE TAKEN NEAR THE DAMAGES AND WERE FOUND WITHIN SPECIFICATION. DURING FUNCTIONAL ANALYSIS A CRACKED CONDITION WAS OBSERVED ON THE HUB THAT PROMOTED THE REPORTED LEAKAGE. NO AIR OR AIR BUBBLES WERE OBSERVED DURING THE FLUSHING TEST. NO AIR BUBBLES WERE OBSERVED ON THE SYRINGE NOR THE WATER THAT CAME OUT OF THE DISTAL TIP. ADDITIONALLY, AN ASPIRATION TEST WAS EXECUTED TO EVALUATE IF THERE WAS ANY AIR ASPIRATION PRESENT ON THE UNIT RECEIVED, DURING THIS ANALYSIS IT WAS CONFIRMED THAT AIR ASPIRATION WAS PRESENT ON THE UNIT. A MICROSCOPIC ANALYSIS WAS PERFORMED TO EVALUATE THE CRACKED CONDITION OBSERVED DURING THE FUNCTIONAL TEST. DURING THIS ANALYSIS FATIGUE STRIATION PATTERNS AND CRACK LINES WERE OBSERVED ON THE SEPARATION WALLS. THE MENTIONED CHARACTERISTICS ARE NORMALLY ATTRIBUTE TO EXCESSIVE TENSILE STRENGTH APPLIED TO A MATERIAL. THE REPORTED ¿LUER HUB-LEAKAGE" WAS CONFIRMED. THE MALFUNCTION ¿LUER HUB-CRACKED¿ WAS ALSO CONFIRMED. THE RETURNED UNIT PRESENTED WITH A CRACKED CONDITION ON THE LUER HUB, WHICH CAUSED THE REPORTED LEAK. THE CRACK LINES AND FATIGUE STRIATIONS FOUND ON THE HUB ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. WHILE THE EXACT CAUSE OF THE CRACK CANNOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS, IT IS ASSUMED THE HUB WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED ITS YIELD STRENGTH PRIOR TO CRACKING. STORAGE OR HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE OPEN OR DAMAGED PACKAGES. INSPECT THE GUIDING CATHETER BEFORE USE TO VERIFY THAT ITS SIZE, SHAPE AND CONDITION ARE SUITABLE FOR THE SPECIFIC PROCEDURE. INSPECT THE GUIDING CATHETER UPON REMOVAL FROM PACKAGING TO VERIFY THAT IT IS UNDAMAGED. WARNING: DO NOT USE A GUIDING CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE WITH AN UNDAMAGED GUIDING CATHETER.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SECTION E ZIP CODE: (B)(6). THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE LUER HUB OF THE 6F .070IN JUDKIN'S RIGHT (JR) 4 100CM VISTA BRITE TIP GUIDING CATHETER WAS OOZING BLOOD ALL OVER AND COULD NOT WORK PROPERLY. THE PROCEDURE WAS COMPLETED BY CHANGING TO A NEW CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. A CONTRALATERAL APPROACH WAS NOT USED. THE VESSEL CHARACTERISTICS AT THE TARGET SITE WERE AS FOLLOWS: NO CALCIFICATION, NO TORTUOSITY, 85% STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. AT THE ACCESS SITE, THE VESSEL CHARACTERISTICS WERE: NO CALCIFICATION, NO TORTUOSITY, NO STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB, BUT IT WAS TORQUED. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES TO THE DEVICE PACKAGING PRIOR TO USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434510 VISTA BRITE TIP CATHETER, PERCUTANEOUS DQY CORDIS US CORP. NA 18243815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DIMAK RADIAL SHEATH.| TERUMO GUIDEWIRE.