BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFORCE¿ PERIPHERAL CROSSING SET

    MDR report key: 9538480 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00027
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 6, 2019
    Report Date
    April 24, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002564176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT: AS REPORTED, DURING A VENOGRAM, A TRIFORCE PERIPHERAL CROSSING SET HUB SEPARATED FROM THE CATHETER. BOTH JUGULAR AND FEMORAL VEINS WERE ACCESSED. THE PATIENT'S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. THE DEVICE WAS NOT USED WITH A POWER INJECTOR. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED OR AT WHAT POINT IN THE PROCEDURE THE HUB SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME DEVICE AND A VENOUS STENT WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE USED KCXS-5.0-35-100-RB-0/DAV-HC CATHETER WAS RETURNED FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED THAT THE SEPARATION OCCURRED AT THE PROXIMAL SHAFT UNDER THE STRAIN RELIEF; RATHER THAN HUB SEPARATION AS INITIALLY REPORTED. THE CATHETER SHAFT WAS ALSO TWISTED AT 2.5CM FROM THE DISTAL TIP. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A REVIEW OF COMPLAINT HISTORY SHOWED NO OTHER COMPLAINTS REPORTED FOR THIS LOT. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE AVAILABLE INFORMATION PROVIDES OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. AN IFU IS ALSO PROVIDED FOR THIS DEVICE, WHICH INCLUDES THE PRECAUTIONS, ¿DEVICE MANIPULATION SHOULD ONLY OCCUR UNDER FLUOROSCOPY," "THE DEVICE SHOULD NOT BE ADVANCED INTO A VESSEL HAVING A REFERENCE VESSEL DIAMETER SMALLER THAN THE SHEATH OUTER DIAMETER," AND, "THE DEVICE SHOULD NOT BE FORCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION.¿ BASED ON THE INFORMATION AVAILABLE, INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K170931. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A VENOGRAM, A TRIFORCE PERIPHERAL CROSSING SET HUB SEPARATED FROM THE CATHETER. BOTH JUGULAR AND FEMORAL VEINS WERE ACCESSED. THE PATIENT'S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. THE DEVICE WAS NOT USED WITH A POWER INJECTOR. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED OR AT WHAT POINT IN THE PROCEDURE THE HUB SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME DEVICE AND A VENOUS STENT WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DURING THE SAME PROCEDURE, THE TIP OF ANOTHER TRIFORCE PERIPHERAL CROSSING SET SHEATH SEPARATED IN THE PATIENT. THIS EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3135 TRIFORCE¿ PERIPHERAL CROSSING SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G56417 9810967 00827002564176

    Patients

    Seq Age Sex Outcome Treatment
    1 KCXS-5.0-35-100-RB-MPB/DAV-HC