BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE?

    MDR report key: 3192679 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04461
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K973945
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: UNIT RETURNED IN A GENERIC PLASTIC BAG AND WITH THE PEEL-OFF LABEL ATTACHED . UNIT PRESENTED THE DISTAL TIP DAMAGED AND BODY WIRE KINKED. THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS THAT THE BODY KINKED ALONG THE BODY AND THE SPRING TIP SEVERELY DAMAGED (COILWIRE UNRAVELED AND THE COREWIRE FRACTURED). DIMENSIONAL INSPECTION: ALL THE OUTER DIAMETER (OD) ARE ACCORDING SPECIFICATIONS. MEASUREMENTS WERE TAKEN WITH DIGITAL MICROMETER. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. THE LAB RETURNED THE FOLLOWING RESULTS: FAILURE ON SITE 1 OCCURRED DUE TO A TENSION OVERLOAD IN A REGION WITH A DEFORMATION OF THE WIRE SURFACE. FAILURE ON SITE 2 OCCURRED DUE TO A TENSION OVERLOAD FOLLOWED BY A BENDING OVERLOAD. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, GUIDEWIRE DIFFICULTY REMOVING AND GUIDEWIRE FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY. A 182 CM LUGE GUIDEWIRE WAS ADVANCED AND PLACED DISTAL TO THE LESION PREVIOUSLY INTERVENED ON AND NOW HAD AN ADDITIONAL LESION DISTAL TO THE PREVIOUSLY PLACED STENT. AFTER SUCCESSFUL PLACEMENT OF THE LUGE GUIDE WIRE DISTAL TO THE LESION, A PRE-DILATATION OF THE LESION WAS COMPLETED WITH A 2.50 X 12 MM EMERGE BALLOON CATHETER AT 6 ATMS. FOLLOWING THAT, A 2.25 X 20 MM PROMUS ELEMENT PLUS DES WAS DELIVERED AND THEN SUCCESSFULLY PLACED AND DEPLOYED TO THE LESION SITE UTILIZING 11ATM¿S. POST-DILATATION WITH THE STENT DELIVERY SYSTEM WAS THEN COMPLETED ALONG THE MORE PROXIMAL SEGMENT OF THE STENT, UTILIZING 20 ATMS. THE STENT DELIVERY SYSTEM WAS THEN WITHDRAWN FROM THE PATIENT WITHOUT ISSUE AND ANGIOGRAPHY OF THE VESSEL TAKEN NOTING EXCELLENT ANGIOGRAPHIC RESULTS. THE RETRIEVAL OF THE 182 CM GUIDE WIRE WAS THEN ATTEMPTED WHICH WAS ¿DIFFICULT¿ AS THERE WAS NOTED RESISTANCE OF THE GUIDE WIRE WHEN RETRIEVING. THE GUIDE WIRE DID THEN "EXIT" THE GUIDE CATHETER AND IT WAS NOTED THAT THE DISTAL SPRING OF THE GUIDE WIRE WAS SHEARED OFF AND UPON INVESTIGATION, TRAPPED BEHIND THE JUST PLACED 2.25 X 20MM PROMUS ELEMENT PLUS DES. SEVERAL ATTEMPTS WERE MADE AT RE-CROSSING THE STENT OF WHICH NONE WERE SUCCESSFUL AND IT WAS DECIDED THAT IT WAS BEST TO LEAVE THE STENT AND SITUATION AS IS, AS THE PATIENT WAS VERY STABLE. THE VESSEL WAS OPEN AND FURTHER ATTEMPTS MAY HAVE CREATED A DIFFERENT SITUATION. THE PATIENT HAD NO FURTHER COMPLICATIONS, DEMONSTRATED TIMI GRADE 3 FLOW, HAD NO CHEST PAIN TO SPEAK OF AND WAS SENT TO THE FLOOR. THE REMAINING PORTION OF THE GUIDE WIRE WAS LEFT IN PLACE BEHIND THE 2.25 X 20 MM PROMUS ELEMENT PLUS STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, GUIDEWIRE DIFFICULTY REMOVING AND GUIDEWIRE FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY. A 182 CM LUGE GUIDEWIRE WAS ADVANCED AND PLACED DISTAL TO THE LESION PREVIOUSLY INTERVENED ON AND NOW HAD AN ADDITIONAL LESION DISTAL TO THE PREVIOUSLY PLACED STENT. AFTER SUCCESSFUL PLACEMENT OF THE LUGE GUIDE WIRE DISTAL TO THE LESION, A PRE-DILATATION OF THE LESION WAS COMPLETED WITH A 2.50 X 12 MM EMERGE BALLOON CATHETER AT 6 ATMS. FOLLOWING THAT, A 2.25 X 20 MM PROMUS ELEMENT PLUS DES WAS DELIVERED AND THEN SUCCESSFULLY PLACED AND DEPLOYED TO THE LESION SITE UTILIZING 11ATMS. POST-DILATATION WITH THE STENT DELIVERY SYSTEM WAS THEN COMPLETED ALONG THE MORE PROXIMAL SEGMENT OF THE STENT, UTILIZING 20 ATMS. THE STENT DELIVERY SYSTEM WAS THEN WITHDRAWN FROM THE PATIENT WITHOUT ISSUE AND ANGIOGRAPHY OF THE VESSEL TAKEN NOTING EXCELLENT ANGIOGRAPHIC RESULTS. THE RETRIEVAL OF THE 182 CM GUIDE WIRE WAS THEN ATTEMPTED WHICH WAS ¿DIFFICULT¿ AS THERE WAS NOTED RESISTANCE OF THE GUIDE WIRE WHEN RETRIEVING. THE GUIDE WIRE DID THEN "EXIT" THE GUIDE CATHETER AND IT WAS NOTED THAT THE DISTAL SPRING OF THE GUIDE WIRE WAS SHEARED OFF AND UPON INVESTIGATION, TRAPPED BEHIND THE JUST PLACED 2.25 X 20MM PROMUS ELEMENT PLUS DES. SEVERAL ATTEMPTS WERE MADE AT RE-CROSSING THE STENT OF WHICH NONE WERE SUCCESSFUL AND IT WAS DECIDED THAT IT WAS BEST TO LEAVE THE STENT AND SITUATION AS IS, AS THE PATIENT WAS VERY STABLE. THE VESSEL WAS OPEN AND FURTHER ATTEMPTS MAY HAVE CREATED A DIFFERENT SITUATION. THE PATIENT HAD NO FURTHER COMPLICATIONS, DEMONSTRATED TIMI GRADE 3 FLOW, HAD NO CHEST PAIN TO SPEAK OF AND WAS SENT TO THE FLOOR. THE REMAINING PORTION OF THE GUIDE WIRE WAS LEFT IN PLACE BEHIND THE 2.25 X 20 MM PROMUS ELEMENT PLUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293400 LUGE? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7491213001J0

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention