BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 2994112 · Received March 8, 2013

    Report

    Report Number
    1016427-2013-00026
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    November 30, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2013-00085.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A LEFT HEART ANGIOGRAM, THERE WAS RESISTANCE BETWEEN AN UNKNOWN CORDIS DIAGNOSTIC CATHETER AND AN EMERALD WIRE, THE PATIENT HAD A GROIN HEMATOMA AND THE SHEATH WAS EXCHANGED, AN INITIAL AVANTI + CANNULA TIP APPEARED DAMAGED AT THE TIP (FLARED, PULLED AND STRETCHED) TIP, AND THE EMERALD WIRE WAS DIFFICULT TO REMOVE FROM THE SECOND AVANTI + SHEATH AND HAD A CORKSCREW-LIKE APPEARANCE AFTER REMOVAL. DURING THE PROCEDURE, THERE WAS A NEED TO DO A DIAGNOSTIC CATHETER EXCHANGE (UNKNOWN CORDIS CATHETER). THE WIRE (EMERALD) WAS PASSED THRU THE CATHETER TO DO THE EXCHANGE. THERE APPEARED TO BE SOME RESISTANCE FELT BY THE PHYSICIAN IN PASSING THE GUIDEWIRE THRU THE CATHETER. THE DIAGNOSTIC CATHETER WAS REMOVED INTACT. PHYSICIAN THEN QUESTIONED A HEMATOMA TO THE RIGHT GROIN AND DECIDED TO EXCHANGE THE FIRST 6.5F AVANTI + FOR A SECOND 6.5F AVANTI +. WHEN THE FIRST SHEATH WAS REMOVED, THE TIP OF THE SHEATH WAS NOTED TO BE IRREGULAR. THE TIP HAD A "FLARED" QUALITY TO ONE SIDE AND WAS NOT SMOOTH OR UNIFORM; IT HAD A "PULLED" OR "STRETCHED" APPEARANCE. WHEN THE SECOND SHEATH WAS INSERTED AND IN PLACE, THE SHEATH INTRODUCER WAS REMOVED WITH THE GUIDEWIRE. IT APPEARED THAT THE GUIDEWIRE REQUIRED A FIRM PULL TO BE REMOVED. AFTER REMOVAL, THE WIRE HAD A "CORKSCREW-LIKE" APPEARANCE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS PER STANDARDS OF PRACTICE (I.E., FLUSHED WITH HEPARINIZED SALINE TO ENSURE PATENCY OF PRODUCT AND VISUALLY INSPECTED). THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY OR FURTHER INCIDENTS. INFORMATION ABOUT ACCESS SITE VESSEL CHARACTERISTICS WERE NOT PROVIDED. (B)(4): ONE NON-STERILE EMERALD DIAGNOSTIC GUIDEWIRE WAS RECEIVED COILED IN A PLASTIC BAG, THE UNIT WAS FOUND WAVY AND DISTAL SECTION WAS FOUND OUT OF SHAPE (COILED). NO OTHER ANOMALIES WERE NOTED. SAMPLE WAS INSPECTED UNDER THE MICROSCOPE, BUT NO OTHER ANOMALIES WERE NOTED APART FROM THE PREVIOUSLY MENTIONED. UNIT WAS INSERTED INTO THE CSI AVANTI PLUS (RECEIVED UNDER COMPLAINT (B)(4)) AND RESISTANCE WAS FELT ON INSERTION/WITHDRAWAL PROCESS. ADDITIONALLY THE SAME TEST WAS PERFORMED WITH ANOTHER GUIDEWIRE (LAB SAMPLE) AND NO FRICTION WAS FELT. THE GUIDEWIRE OUTSIDE DIAMETER WAS MEASURED, AND IT WAS FOUND WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE FAILURE REPORTED BY THE CUSTOMER AS EMERALD WIRE RESISTANCE/FRICTION AND CORKSCREW-LIKE APPEARANCE WAS CONFIRMED, THE PRODUCT WAS TESTED AND RESISTANCE WAS FELT ON INSERTION/WITHDRAWAL PROCESS; HOWEVER, THE UNKNOWN GUIDE CATHETER AND THE SECOND AVANTI SHEATH THAT WERE INVOLVED IN THE COMPLAINT WERE NOT RETURNED FOR ANALYSIS. RESISTANCE FELT IS RELATED TO THE CONDITION OF THE GUIDEWIRE (COILED), HOWEVER THE EXACT CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER AND THE CAUSE OF THE CONDITION OF THE RECEIVED UNIT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANALYSIS INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. IT IS POSSIBLE THAT PROCEDURAL FACTORS (RESISTANCE BETWEEN THE DIAGNOSTIC CATHETER, DIFFICULT REMOVAL FROM THE SECOND SHEATH) OR HANDLING MAY HAVE CONTRIBUTED WITH THE REPORTED CONDITION. THE COMPLAINT REPORTED BY THE CUSTOMER OF THE AVANTI SHEATH TIP DAMAGE WAS CONFIRMED SINCE THE CANNULA WAS RECEIVED FLARED AT THE DISTAL TIP AND PRESENTED A STRETCHED AND RAGGED APPEARANCE FROM 6.0 CM FROM HUB UP TO DISTAL END. THE EXACT CAUSE OF FLARED AT DISTAL TIP CONDITION AND STRETCHED /RAGGED APPEARANCE FOUND ON THE CSI CANNULA COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. ANALYSIS RESULTS DO NOT SUGGEST THAT THESE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS, HANDLING AND STORAGE PROCESS MAY CONTRIBUTE TO THE FAILURE AS REPORTED. VESSEL CHARACTERISTICS AT THE INSERTION SITE MAY ALSO HAVE CONTRIBUTED TO THIS CONDITION (I.E. CALCIFICATION, SCARRING). THE REPORTED HEMATOMA COULD NOT BE CONFIRMED, BUT MAY HAVE BEEN THE RESULT OF PROCEDURAL FACTORS OR VESSEL CHARACTERISTICS. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING OR DESIGN ISSUE RELATED TO THE REPORTED EVENTS, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION INDICATES THAT THERE WAS WITHDRAW DIFFICULTY REMOVING THE GUIDEWIRE FROM THE VESSEL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A LEFT HEART CATH ANGIOGRAM, THE SHEATH TIP OF AN AVANTI PLUS "FLARED' AT BOTTOM OF CANNULA". IT WAS DESCRIBED AS NO LONGER SMOOTH, UNIFORM CIRCLE WHEN REMOVED FROM THE PATIENT. IT APPEARED TO BE PULLED OR ELONGATED IN ONE AREA. ALSO, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE/FRICTION WHEN REMOVING AN EMERALD DIAGNOSTIC GUIDEWIRES OUT OF THE CATHETER. THE GUIDEWIRE WAS NOTED TO BE "PULLED" OUT OF SHAPE. IT APPEARED LIKE A "CORK SCREW" ONCE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED AND PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT FURTHER INCIDENTS. THERE WAS A NEED TO DO A DIAGNOSTIC CATHETER EXCHANGE. THE WIRE WAS PASSED THRU THE CATHETER TO DO THE EXCHANGE. THERE APPEARED TO BE SOME RESISTANCE FELT BY THE PHYSICIAN IN PASSING THE GUIDEWIRE THRU THE CATHETER. THE DIAGNOSTIC CATHETER WAS REMOVED INTACT. PHYSICIAN THEN QUESTIONED A HEMATOMA TO THE RIGHT GROIN. HE DECIDED TO EXCHANGE THE SHEATH. HE REMOVED THE FIRST SHEATH, 6.5FR CORDIS FOR A SECOND CORDIS 6.5FR SHEATH. WHEN THE FIRST SHEATH WAS REMOVED THE TIP OF THE SHEATH WAS NOTED TO BE IRREGULAR. THE TIP HAD A "FLARED" QUALITY TO THE ONE SIDE. IT WAS NOT SMOOTH OR UNIFORM; IT HAD A "PULLED" OR "STRETCHED APPEARANCE. WHEN THE SECOND SHEATH WAS INSERTED AND IN PLACE, THE SHEATH INTRODUCER WAS REMOVED WITH THE GUIDEWIRE. IT APPEARED THAT THE GUIDEWIRE REQUIRED A FIRM PULL TO BE REMOVED. THE WIRE HAD A "CORKSCREW-LIKE" APPEARANCE TO IT WHEN IT WAS OUT. ALL PRODUCTS USED WERE CORDIS PRODUCTS FOR THIS PROCEDURE. PREPARATION OF SHEATH, CATHETERS AND WIRES AS PER OUR STANDARDS OF PRACTICE (IE/ FLUSHED WITH HEPARINIZED SALINE TO ENSURE PATENCY OF PRODUCT AND VISUALLY INSPECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100153 EMERALD DIAGNOSTIC GUIDEWIRES CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1