BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 8545901 · Received April 24, 2019

    Report

    Report Number
    1820334-2019-00948
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 10, 2019
    Report Date
    August 15, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002183735
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: D10 & H3. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S 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. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS ONE NONCONFORMING EVENT WHICH COULD POTENTIALLY CONTRIBUTE TO THIS FAILURE MODE. THIS NONCONFORMANCE WAS FOR SHAFT DAMAGE INSIDE THE STRAIN RELIEF OF A DEVICE. WHILE THIS MAY BE RELATED TO THE REPORTED FAILURE, IT SHOULD BE NOTED THAT THE EFFECTED UNIT WAS SCRAPPED PRIOR TO ORDER COMPLETION. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES THE DEVICE IS FOR USE IN SMALL VESSELS OR SUPER SELECTIVE ANATOMY FOR DIAGNOSTIC AND INTERVENTIONAL PROCEDURES, INCLUDING PERIPHERAL USE.¿ PRECAUTIONS LISTED IN THE IFU INCLUDE: ¿THE CATHETER SHOULD NOT BE ADVANCED INTO A VESSEL HAVING A REFERENCE VESSEL DIAMETER SMALLER THAN THE CATHETER OUTER DIAMETER.¿ AND ¿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.¿. THE INSTRUCTIONS FOR USE ALSO ADVISE THE USER THAT THE SURFACE OF THE CATHETER ¿MAY BECOME DRY IF NOT USED IMMEDIATELY AFTER ACTIVATION¿. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT COULD NOT BE TRACED TO THE DEVICE BUT TO THE PATIENT¿S CONDITION. REPORTEDLY, THE TARGET LESION WAS ¿VERY CALCIFIED¿ AND SO MUCH RESISTANCE WAS NOTED THAT THE USER HAD TO APPLY TORQUE TO THE DEVICE, CONTRIBUTING TO THE SEPARATION. 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

    OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K122796. (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 AN ANGIOGRAM WITH INTERVENTION OF THE LEFT LEG, A CXI SUPPORT CATHETER SEPARATED IN THE ANTERIOR TIBIAL ARTERY. THE (B)(6) MALE PATIENT, WEIGHING (B)(6) POUNDS, REPORTEDLY HAD A HISTORY SIGNIFICANT FOR ULCERS ON THE TOES AND NO BLOOD FLOW BELOW THE KNEE. ACCESS WAS OBTAINED IN THE GROIN AND AN UNKNOWN 6 FRENCH SHEATH AND UNKNOWN WIRE GUIDE WERE USED DURING THE PROCEDURE. A POWER INJECTOR WAS NOT USED. DURING THE PROCEDURE, RESISTANCE WAS REPORTED, AND THE PHYSICIAN ¿STRUGGLED¿ TO ADVANCE THE CATHETER OR APPLY TORQUE TO THE DEVICE. WHILE THE PHYSICIAN WAS ATTEMPTING TO CROSS A ¿VERY CALCIFIED¿ LESION, A 20-CENTIMETER SEGMENT OF THE DEVICE SEPARATED FROM THE TIP. THE PHYSICIAN WAS ABLE TO REMOVE THE SEPARATED PORTION OF THE DEVICE THROUGH AN UNKNOWN 5 FRENCH CATHETER VIA A SMALL INCISION IN THE SKIN ABOVE THE ACCESS SITE. THE INTENDED PROCEDURE WAS ABORTED, AND THE PATIENT WILL RETURN FOR ANOTHER INTERVENTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338422 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G18373 8562431 00827002183735

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention