BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CROSS SUPPORT CATHETER

    MDR report key: 5044576 · Received September 1, 2015

    Report

    Report Number
    5044576
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SPECTRANETICS CORP
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE QUICK CROSS CATHETER BROKE OFF IN RIGHT FEM POP BYPASS GRAFT. AN OPEN EXPLORATION WAS PERFORMED AND THE TIP WAS SUCCESSFULLY RETRIEVED. THE SURGEON DOCUMENTED THE FOLLOWING IN HIS OPERATIVE REPORT: "... I THEN INITIALLY ATTEMPTED TO PASS A CROSS CATHETER THROUGH THIS AREA THERE IS RESISTANCE IN THE COMMON ILIAC TO EXTERNAL ILIAC ARTERY STENT JUNCTION. WIRE EXCHANGES WERE MADE FOR A MAGIC TORQUE WIRE WHICH WAS ADVANCED THROUGH THIS REGION AND DOWN TO THE LEVEL OF THE OCCLUDED FEMORAL-POPLITEAL BYPASS GRAFT. THREE THOUSAND UNITS OF INTRAVENOUS HEPARIN WERE GIVEN AS A BOLUS AT THIS TIME. I WAS ABLE TO ADVANCE A 6 FRENCH ANSEL INTRODUCER SHEATH OVER THE AORTIC BIFURCATION AND PLACED IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY STENT. I THEN ADVANCED A Q-QUICK CROSS CATHETER OVER THE MAGIC TORQUE WIRE AND THE COMBINATION OF QUICK CROSS AND MAGIC TORQUE WIRE IN ADVANCED FULL LENGTH THROUGH THE FEMORAL-POPLITEAL BYPASS GRAFT WHICH HAD BEEN NOTED TO COMPLETELY OCCLUDED DOWN TO THE LEVEL OF THE PREVIOUSLY PLACED STENTS IN THE REGION OF THE DISTAL BYPASS GRAFT STENOSIS. I WAS ABLE TO ADVANCE THE WIRE PAST THE STENTED REGION BUT NOT INTO THE NATIVE POPLITEAL ARTERY THE CATHETER WAS ADVANCED DOWN TO THIS REGION ALSO. THROUGH THE CATHETER A STIFF AND SOFT ANGLED GLIDEWIRE WERE PASSED IN ATTEMPTS WERE MADE TO CROSS THE OCCLUDED POPLITEAL ARTERY WITH THIS WAS UNSUCCESSFUL. I THEN ATTEMPTED TO WITHDRAW THE QUICK CROSS CATHETER WITH THE INITIAL PLANS TO ANGIOPLASTY THE ILIAC ARTERY AND STENOSES, ADVANCED THE 6 FRENCH SHEATH DOWN TO THE COMMON FEMORAL ARTERY FOR IMPROVED SUPPORT AND ATTEMPT TO CROSS THE OCCLUDED DISTAL ASPECT OF THE FEMOROPOPLITEAL BYPASS GRAFT. CATHETER AND GUIDEWIRE COMBINATION WOULD NOT RELEASE. ATTEMPTS TO MANIPULATE THE CATHETER OVER THE MAGIC TORQUE WIRE WERE UNSUCCESSFUL. I THEN DECIDED TO WITHDRAW BOTH CATHETER AND GUIDEWIRE AT THE SAME TIME THERE WAS AN ABRUPT RELEASE OF THE CATHETER AND UNDER FLUOROSCOPY THE DISTAL ASPECT OF THE CATHETER WAS SEEN TO BE LODGED IN THE STENTED REGION OF THE FEMOROPOPLITEAL BYPASS GRAFT AND THE REMAINDER OF THE CATHETER AND MAGIC TORQUE WIRE WERE RETRIEVED. THE 6 FRENCH SHEATH WAS LEFT IN THE POSITION NOTED. IN THE DECISION WAS MADE TO OPEN THE RIGHT THIGH..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577903 QUICK-CROSS SUPPORT CATHETER CATHETER, PERCUTANEOUS DQY SPECTRANETICS CORP FQQ15EOA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR