BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 11519063 · Received March 18, 2021

    Report

    Report Number
    1820334-2021-00969
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Report Date
    August 4, 2021
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. EVENT SUMMARY A REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER BROKE. THE CATHETER WAS ON A WIRE GUIDE WHEN THE FRACTURE OCCURRED. NO PORTION OF THE DEVICE REMAINED WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED BY "OTHER MEANS". THIS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED. INVESTIGATION - EVALUATION A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF DOCUMENTATION, SPECIFICATIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. AS THE RPN IS UNKNOWN AND THERE A LIMITED EVENT DETAILS, THERE ARE NO COMPLAINTS SIMILAR ENOUGH TO THIS EVENT TO BE USED AS A REPRESENTATIVE DEVICE FOR DEVICE ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE COMPLETED DUE TO LACK OF INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿THE CXI SUPPORT CATHETER IS INTENDED FOR USE IN SMALL VESSEL OR SUPERSELECTIVE ANATOMY FOR DIAGNOSTIC AND INTERVENTIONAL PROCEDURES, INCLUDING PERIPHERAL USE.¿ PRECAUTIONS: ¿THE CATHETER SHOULD NOT BE ADVANCED INTO A VESSEL HAVING A REFERENCE VESSEL DIAMETER SMALLER THAN THE CATHETER OUTER DIAMETER.¿ ¿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 ORE REMOVE THE OBSTRUCTION.¿ HOW SUPPLIED: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ COOK HAS CONCLUDED COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THIS INCIDENT. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE MASTER RECORD, AND DESIGN VERIFICATION TESTING PROVIDE OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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 NEW INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL REPORTER OCCUPATION: LEAD TECH. PMA/510K # K122796 OR K160884. 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

    A REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER BROKE. THE CATHETER WAS ON A WIRE GUIDE WHEN THE FRACTURE OCCURRED. NO PORTION OF THE DEVICE REMAINED WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED BY "OTHER MEANS". THIS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413801 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1