BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFORCE¿ PERIPHERAL CROSSING SET

    MDR report key: 9538581 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00029
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    December 6, 2019
    Report Date
    May 19, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: AS REPORTED, DURING A VENOGRAM, A TRIFORCE PERIPHERAL CROSSING SET SHEATH SEPARATED AT THE TIP AND REMAINED IN THE PATIENT. 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 TIP SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME DEVICE AND A VENOUS STENT WAS USED TO KEEP THE SEPARATED PORTION OF THE DEVICE IN PLACE. 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, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE USED TRIFORCE FLEXOR OUTER SHEATH WAS RETURNED FOR INVESTIGATION. BIOMATTER WAS PRESENT ON THE DEVICE. APPROXIMATELY 4MM OF THE DISTAL TIP IS SEPARATED AND JAGGED. THE SEPARATED PIECE WAS ATTACHED ONTO THE DISTAL END OF SHEATH BY THE TNRT LINER. THE SHEATH TIP WAS ALSO SPLIT. NO OTHER DAMAGE WAS NOTED TO THE DEVICE. ANOTHER PORTION OF THE SHEATH TIP THAT WAS SEPARATED WAS NOT RETURNED, AS IT WAS REPORTED THAT A VENOUS STENT WAS USED TO KEEP THE SEPARATED PORTION OF THE DEVICE IN PLACE IN THE PATIENT. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. REVIEWS OF THE MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE ALSO CONDUCTED, AND NO GAPS WERE DISCOVERED. THE AVAILABLE INFORMATION PROVIDES OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE PRODUCT IS PACKAGED WITH INSTRUCTIONS FOR USE WHICH CAUTION, ¿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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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. (B)(4). 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 SHEATH SEPARATED AT THE TIP AND REMAINED IN THE PATIENT. 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 TIP SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME DEVICE AND A VENOUS STENT WAS USED TO KEEP THE SEPARATED PORTION OF THE DEVICE IN PLACE. 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, ANOTHER TRIFORCE PERIPHERAL CROSSING SET CATHETER SEPARATED AT THE HUB OF THE DEVICE. THIS WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259 TRIFORCE¿ PERIPHERAL CROSSING SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KCXS-5.0-35-100-RB-0/DAV-HC