BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 9823858 · Received March 12, 2020

    Report

    Report Number
    1820334-2020-00599
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 11, 2020
    Report Date
    June 29, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY IT WAS REPORTED THAT THE TIP OF A CXI SUPPORT CATHETER SEPARATED FROM THE SHAFT DURING A PROCEDURE AND HAD TO BE REMOVED FROM THE PATIENT. THE ACCESS SITE FOR THE WIRE WAS THE FEMORAL ARTERY, BUT THE TARGET LOCATION REMAINS UNKNOWN. WHILE TRYING TO CROSS AN OCCLUSION, THERE WAS A "HEAVY AMOUNT OF TORQUEING AND TWISTING". THE FIRST CATHETER THAT WAS USED SEPARATED AT THE HUB, REPORTED IN MDR: 1820334-2020-00598. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. DURING USE OF THIS CATHETER, IT WAS REPORTED "THERE WAS SOME TORQUEING", AND SUBSEQUENTLY THE TIP OF THE CATHETER SEPARATED FROM THE SHAFT. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE TIP OF THE CATHETER FROM THE PATIENT. A MICROPUNCTURE WAS USED TO GAIN ACCESS, AND OTHER CATHETERS WERE ALSO USED DURING THE PROCEDURE. IT IS UNKNOWN IF THE PATIENT'S ANATOMY WAS TORTUOUS OR CALCIFIED. IT WAS REPORTED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. INVESTIGATION - EVALUATION REVIEWS OF THE DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED. THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. NO GAPS WERE DISCOVERED IN THE MANUFACTURING INSTRUCTIONS OR QUALITY CONTROL PROCEDURES FOR THIS DEVICE. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT IS PACKAGED WITH INSTRUCTIONS FOR USE, WHICH STATE, "THE CATHETER SHOULD NOT BE ADVANCED 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 CAN BE TRACED TO PATIENT ANATOMY, AS THE PHYSICIAN REPORTED "HEAVY AMOUNT OF TORQUEING AND TWISTING," SUGGESTING AN INABILITY TO TRANSFER TORQUE TO THE TIP OF THE DEVICE. 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

    CONCOMITANT MEDICAL PRODUCTS: ADDITIONAL DEVICES USED INCLUDES A MICROPUNCTURE TO GAIN ACCESS AND LIKELY OTHER CATHETERS WHICH WERE UNSPECIFIED. OCCUPATION: LAB MANAGER. PMA/510(K): K160884. (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

    IT WAS REPORTED THAT THE TIP OF A CXI SUPPORT CATHETER SEPARATED FROM THE SHAFT DURING A PROCEDURE AND HAD TO BE REMOVED FROM THE PATIENT. THE ACCESS SITE FOR THE WIRE WAS THE FEMORAL ARTERY, BUT THE TARGET LOCATION REMAINS UNKNOWN. WHILE TRYING TO CROSS AN OCCLUSION, THERE WAS A "HEAVY AMOUNT OF TORQUING AND TWISTING". THE FIRST CATHETER THAT WAS USED SEPARATED AT THE HUB, REPORTED IN MDR: 1820334-2020-00598. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. DURING USE OF THIS CATHETER, IT WAS REPORTED "THERE WAS SOME TORQUING", AND SUBSEQUENTLY THE TIP OF THE CATHETER SEPARATED FROM THE SHAFT. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE TIP OF THE CATHETER FROM THE PATIENT. A MICROPUNCTURE WAS USED TO GAIN ACCESS, AND OTHER CATHETERS WERE ALSO USED DURING THE PROCEDURE. IT IS UNKNOWN IF THE PATIENT'S ANATOMY WAS TORTUOUS OR CALCIFIED. IT WAS REPORTED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285477 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other