BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST SUPPORT WIRE GUIDE

    MDR report key: 20491289 · Received October 21, 2024

    Report

    Report Number
    3002808486-2024-00225
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 21, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002467293
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K220137. AFTER INVESTIGATION WAS COMPLETED 07OCT2024, EVENT IS CONSIDERED REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: THE LUNDERQUIST GUIDE WIRE REPORTEDLY GOT STUCK IN THE ENDOGRAFT DELIVERY SYSTEM AND BEGAN TO UNWIND. THE ENTIRE SYSTEM NEEDED TO BE REMOVED AND CONVERTED TO AN OPEN ABDOMINAL AORTA ANEURYSM (AAA) REPAIR. THE WIRE GUIDE WAS RETURNED FOR ANALYSIS. HOWEVER, THE TIP HAD FRACTURED AND WAS NOT RETURNED. A SINGLE PHOTOGRAPH OF THE RETRIEVED LUNDERQUIST WIRE DEMONSTRATES THE MANDREL WIRE FRACTURED FROM THE TIP WITH UNWINDING OF THE OUTER COILED COMPONENT OF THE WIRE. THE FIRST SHORT FLUOROSCOPIC VIDEO CLIP DEMONSTRATES SPINNING OF THE OMNI FLUSH CATHETER WITHIN THE AORTIC BODY INDICATING SUCCESSFUL SELECTION OF THE CONTRALATERAL LIMB GATE AND CATHETER WITHIN THE BODY OF THE GRAFT. THE SECOND SHORT FLUOROSCOPIC VIDEO DEMONSTRATES WHAT APPEARS TO BE SIGNIFICANT DISTORTION OF THE ENDOGRAFT BODY. THERE IS MOVEMENT OF WHAT IS PRESUMED TO BE IN THE BROKEN AND PARTIALLY UNWOUND LUNDERQUIST WIRE WITH RETRACTION OF THE WIRE AND THE ENDOGRAFT BEING DISPLACED CAUDALLY, INDICATING THE WIRE IS ENTANGLED WITH THE GRAFT. IT DOES NOT APPEAR THE CONTRALATERAL LIMB HAS BEEN DEPLOYED AT THIS POINT. AN OMNI FLUSH CATHETER APPEARS TO MOVE CAUDALLY FROM THE GRAFT BODY INTO THE GATE, BUT ITS ORIENTATION TO THE BROKEN WIRE IS DIFFICULT TO DISCERN. POTENTIALLY THIS CATHETER WAS ADVANCED OVER THE WIRE IN ATTEMPTS TO FREE THE WIRE. BASED ON THE COMPLAINT REPORT AND THE LIMITED IMAGES SUBMITTED FOR REVIEW, IT APPEARS THE OPERATING PHYSICIAN IN ALL LIKELIHOOD INADVERTENTLY ENTANGLED OR ENGAGED THE FLOPPY TIP A LUNDERQUIST WIRE WITH ONE OF THE SUPRARENAL STRUTS OF THE ENDOGRAFT. GIVEN THIS IS A NON-HYDROPHILIC WIRE, INITIAL ATTEMPTS AT RETRACTING THE WIRE LIKELY ONLY FURTHER ENGAGE THE WIRE WITH THE ENDOGRAFT MATERIAL RESULTING IN THE WIRE GETTING "STUCK". UNFORTUNATELY, THE WIRE IS DESIGNED TO WITHSTAND A CERTAIN AMOUNT OF TENSILE FORCES, AND THIS IS EXCEEDED RESULTING IN FRACTURE OF THE INNER MANDREL FROM THE DISTAL TIP RESULTING IN UNWINDING OF THE WIRE. FROM THE VIDEO IT DOES NOT APPEAR THE WIRE WAS STUCK IN THE MEDTRONIC DEPLOYMENT SYSTEM BUT RATHER STUCK WITHIN THE ENDOGRAFT BODY. THE WIRE WAS NOT UP AND OVER THE AORTIC BIFURCATION AS REPORTED. UNLESS THERE WAS A MANUFACTURING DEFECT WITH THE WIRE, WHICH SHOULD HAVE BEEN RECOGNIZED PRIOR TO INSERTING THE WIRE, THIS IS LIKELY USER ERROR. POTENTIALLY, THIS COMPLICATION COULD HAVE BEEN AVOIDED IF THE LUNDERQUIST WIRE WAS ADVANCED ALL THE WAY INTO THE THORACIC AORTA DURING MANIPULATION, AND DURING WITHDRAWAL STOPPING IN ANY RESISTANCE ENCOUNTERED IN ORDER TO USE AN ADDITIONAL CATHETER SUCH AS A GLIDE CATHETER TO FREE THE WIRE FROM THE ENTANGLEMENT WITH THE SUPRARENAL STRUTS. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH PROCEDURES AND ACCORDING TO SPECIFICATIONS. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE OUTSIDE OF THE GUIDEWIRE HAS BECOME LOOSE AND AS A RESULT, HAS BECOME STUCK IN THE GRAFT. CONVERSION WAS NECESSARY. PER COMPLAINT FORM: THE LUNDERQUIST WAS BROUGHT IN, A MEDTRONIC DELIVERY SYSTEM WAS BROUGHT IN OVER THE WIRE, ALL NORMAL STEPS WERE DONE. DURING BRINGING IN THE CONTRAL LATERAL LEG THE WIRE WAS STUCK IN THE DELIVERY SYSTEM. PULLING OUT WAS NOT POSSIBLE. PATIENT WAS CONVERTED TO AN OPEN PROCEDURE, EVERYTHING WAS TAKEN OUT AND THE PATIENT RECEIVED A SURGICAL GRAFT. BOTH MAIN DEVICE AND CONTROL LATERAL LEG WERE ALREADY DEPLOYED WHEN THE LUNDERQUIST WAS STUCK IN THE MEDTRONIC DEVICE. CLINICAL SPECIALIST FROM MEDTRONIC SAID THE WIRE WAS OVER THE BIFURCATION, BUT IN THE ATTACHED VIDEO THE WIRE IS IN THE AORTA. NOBODY UNDERSTOOD WHY THE WIRE WAS STUCK, ALL NORMAL STEPS WERE TAKEN. PATIENT OUTCOME: AFTER OPEN PROCEDURE, ALL PARTS HAVE BEEN TAKEN OUT. AN ENDOVASCULAR AORTIC REPAIR (EVAR) WAS CONVERTED TO AN OPEN PROCEDURE IN ORDER TO REMOVE THE STENT FROM MEDTRONIC AND LUNDERQUIST WIRE. BECAUSE OF THE PRODUCT FAILURE AN OPEN PROCEDURE WAS PERFORMED, PATIENT WENT TO IC AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930714 LUNDERQUIST SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G46729 E4568336 00827002467293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other