BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 3759112 · Received April 18, 2014

    Report

    Report Number
    1016427-2014-00049
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED: THE PRODUCT CATALOG AND LOT NUMBER WAS RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: GC: 5 F JL-4 GUIDE CATHETER LAUNCHER, MEDTRONICS, USA; GW: 0.014¿ BMW PTCA.THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A LITERATURE ARTICLE STATED THAT, IN VIEW OF SEVERE RESISTANCE TO THE PROGRESSION OF A STANDARD 0.035¿ CORDIS GUIDE WIRE, CONTRAST WAS INJECTED THROUGH SIDE PORT OF INTRODUCER SHEATH THAT DOCUMENTED SEVERE TORTUOSITY ASSOCIATED WITH PERFORATION IN COURSE OF THE RADIAL ARTERY (RA). A 0.014¿ BMW PTCA GUIDE WIRE WAS CAREFULLY NEGOTIATED ACROSS THE TORTUOUS SEGMENT AND A NON-CORDIS 5 F JL-4 GUIDE CATHETER WAS NEGOTIATED USING BALLOON-ASSISTED TRACKING (BAT), PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS THEN COMPLETED SUCCESSFULLY. CONTRAST INJECTION THROUGH SIDE PORT OF INTRODUCER SHEATH REVEALED COMPLETELY SEALED PERFORATION. THE PERFORATION WAS SEALED BECAUSE THE GUIDE CATHETER ACTED AS AN INTERNAL HEMOSTATIC DEVICE DURING THE DURATION OF THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. VESSEL PERFORATION/ARTERIAL INJURY IS A KNOWN PROCEDURAL COMPLICATION DURING USE OF THIS DEVICE. THE IFU CAUTIONS THAT, IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE. WITHOUT THE RETURN OF THE ACTUAL COMPLAINT PRODUCT THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED, NOR CAN ANY CONCLUSION REGARDING ROOT CAUSE BE DRAWN. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AS NOTED IN THE PUBLICATION BY PATEL ET AL BALLOON-ASSISTED TRACKING: A MUST-KNOW TECHNIQUE TO OVERCOME DIFFICULT ANATOMY DURING TRANSRADIAL APPROACH, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 83 (2014) 211-220. THE ARTICLE STATED, IN VIEW OF SEVERE RESISTANCE TO THE PROGRESSION OF A STANDARD 0.035¿ CORDIS GUIDE WIRE, CONTRAST WAS INJECTED THROUGH SIDE PORT OF INTRODUCER SHEATH THAT DOCUMENTED SEVERE TORTUOSITY ASSOCIATED WITH PERFORATION IN COURSE OF THE RADIAL ARTERY (RA). A 0.014¿ BMW PTCA GUIDE WIRE WAS CAREFULLY NEGOTIATED ACROSS THE TORTUOUS SEGMENT AND A NON-CORDIS 5 F JL-4 GUIDE CATHETER WAS NEGOTIATED USING BALLOON-ASSISTED TRACKING (BAT), PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS THEN COMPLETED SUCCESSFULLY. CONTRAST INJECTION THROUGH SIDE PORT OF INTRODUCER SHEATH REVEALED COMPLETELY SEALED PERFORATION. THE PERFORATION WAS SEALED BECAUSE THE GUIDE CATHETER ACTED AS AN INTERNAL HEMOSTATIC DEVICE DURING THE DURATION OF THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237287 EMERALD DIAGNOSTIC GUIDEWIRES CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0813003

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R