BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GC 5F 056 XB 3.5 LBT

    MDR report key: 13012003 · Received December 15, 2021

    Report

    Report Number
    9616099-2021-05193
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    May 6, 2021
    Report Date
    December 15, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQY
    UDI-DI
    20705032015223
    PMA / PMN Number
    K000715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, THE TIP OF 5F .056 EXTRA BACK-UP (XB) 3.5 LONG VISTA BRITE TIP GUIDING CATHETER WAS DEFECTIVE. AS A RESULT, THE CATHETER WAS CHANGED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN AN INTERVENTIONAL CARDIOLOGY PROCEDURE. ONE NON-STERILE UNIT OF CATHETER GC 5F 056 XB 3.5 LBT WAS FOR ANALYSIS. THE DEVICE WAS UNPACKED TO PROCEED WITH THE PRODUCT EVALUATION. DURING VISUAL INSPECTION, THE UNIT PRESENTED WITH A TORN CONDITION LOCATED APPROXIMATELY AT 6.1 CM FROM DISTAL TIP. ALSO, A COUPLE OF COMPRESSED CONDITIONS WERE FOUND LOCATED APPROXIMATELY AT 23.5 CM FROM DISTAL TIP. A TWISTED CONDITION WAS FOUND LOCATED APPROXIMATELY AT 39.7 CM FROM DISTAL TIP AND A KINKED CONDITION WAS FOUND APPROXIMATELY AT 85.4 CM FROM DISTAL TIP. INNER DIAMETER (ID) AND OUTER DIAMETER (OD) MEASUREMENTS WERE TAKEN NEAR THE DAMAGES AND WERE FOUND WITHIN SPECIFICATION. SEM ANALYSIS WAS PERFORMED, AND RESULTS SHOWED THAT THE TORN AREA OF THE BODY/SHAFT FROM THE GC 5F 056 XB 3.5 LBT UNIT PRESENTED EVIDENCE OF ELONGATIONS. ALSO, DUCTILE DIMPLES WERE FOUND ON THE SEPARATED BRAID WIRE SURFACES. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18006799 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT BY THE CUSTOMER AS ¿CATHETER (BODY/SHAFT) ¿ CRACKED - IN-PATIENT¿ WAS CONFIRMED SINCE A TORN CONDITION WAS FOUND NEAR THE DISTAL TIP. THE ELONGATIONS FOUND ON THE BODY/SHAFT MATERIAL OF THE UNIT ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE BODY/SHAFT MATERIAL WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE BODY/SHAFT MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. USER TECHNIQUE, VESSEL CHARACTERISTICS AND/OR INAPPROPRIATE SELECTION OF A CONCOMITANT DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, 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), ¿IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER. TORQUING THE GUIDING CATHETER EXCESSIVELY WHILE KINKED MAY CAUSE DAMAGE WHICH COULD RESULT IN POSSIBLE SEPARATION ALONG THE CATHETER SHAFT. SHOULD THE GUIDING CATHETER SHAFT BECOME SEVERELY KINKED, WITHDRAW THE ENTIRE SYSTEM (GUIDING CATHETER, GUIDEWIRE, AND CATHETER SHEATH INTRODUCER).¿ BASED ON THE INFORMATION AVAILABLE, PRODUCT ANALYSIS, AND THE PHR REVIEW, 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.

    Description of Event or Problem · 0

    AS REPORTED, THE TIP OF 5F .056 EXTRA BACK-UP (XB) 3.5 LONG VISTA BRITE TIP GUIDING CATHETER WAS DEFECTIVE. AS A RESULT THE CATHETER WAS CHANGED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN AN INTERVENTIONAL CARDIOLOGY PROCEDURE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WAS RETURNED FOR EVALUATION. AS PER PRODUCT EVALUATION, DURING THE VISUAL INSPECTION, THE UNIT PRESENTED A TORN CONDITION LOCATED APPROXIMATELY AT 6.1 CM FROM DISTAL TIP. DUE THE TORN CONDITION FOUND ON THE UNIT, A SEM ANALYSIS WAS PERFORMED, AND RESULTS SHOWED THAT THE TORN AREA OF THE BODY/SHAFT FROM THE GC 5F 056 XB 3.5 LBT UNIT PRESENTED EVIDENCE OF ELONGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910788 GC 5F 056 XB 3.5 LBT CATHETER, PERCUTANEOUS DQY CORDIS CORPORATION 5560540L 18006799 20705032015223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown