BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVOY 5F GUIDING CATHETERS

    MDR report key: 1883850 · Received October 27, 2010

    Report

    Report Number
    9616099-2010-00816
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 5, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K000715
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE UNIT OF ENVOY 5F 056 STR WAS RECEIVED COILED IN AN UNKNOWN POUCH. BLOOD RESIDUES WERE FOUND IN THE INNER SIDE OF THE CATHETER. CATHETER EXTERNAL COMPONENTS (BODY SHAFT AND HUB) WERE VISUALLY INSPECTED USING A MICROSCOPE DEVICE AND NO DAMAGES/ANOMALIES OR MISSING PARTS WERE DETECTED. THE CATHETER WAS FLUSHED ACCORDING TO DP 12155047 IN ORDER TO VERIFY THE PART FOR FOREIGN MATERIALS INSIDE THE CATHETER AND NO FOREIGN MATERIALS WERE FOUND. THE CATHETER WAS LENGTHWISE CUT IN ORDER TO INSPECT THE INNER SIDE OF THE UNIT FOR DAMAGES AND/OR MISSING COATING (PTFE) AND NO MISSING COATING NOR DAMAGES WERE OBSERVED THROUGHOUT THE CATHETER INNER LENGTH. THE INSPECTION WAS PERFORMED USING A MICROSCOPIC DEVICE. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT REPORTED BY THE CUSTOMER "FOREIGN MATERIAL" COULD NOT BE CONFIRMED DUE THAT NO COATING DAMAGES OR MISSING PARTS WERE OBSERVED THROUGHOUT THE CATHETER INNER AND OUTER LENGTH. CONTROLS ARE IN PLACE TO VERIFY THE CATHETER FOR THIS TYPE OF CONDITIONS; THE PRODUCED CATHETERS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. ALSO, SEVERAL INSPECTIONS ARE PERFORMED THROUGH ALL THE GUIDING CATHETER ASSEMBLY PROCESS OPERATIONS. THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED, NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED, PROCEDURAL FACTORS MAY CONTRIBUTE TO FAILURE AS REPORTED. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A THROMBOLYSIS PROCEDURE OF THE VERTEBRAL ARTERY, INITIALLY THE VERTEBRAL ARTERY WAS NOT SHOWN WITH ANGIOGRAPHY. THEN WHEN AORTIC ANGIOGRAPHY WAS PERFORMED USING THE ENVOY GUIDING CATHETER ((B)(4)) THE VERTEBRAL ARTERY WAS CONFIRMED WITH NOTHING UNUSUAL AT THIS POINT. WITH FOLLOW-UP ANGIOGRAPHY OF THE VERTEBRAL ARTERY AND ENTIRE BRAIN WAS PERFORMED USING AN UNKNOWN ANGIOGRAPHY CATHETER, FOREIGN MATTER WAS NOTED THROUGH THE IMAGE. BASED ON THE X-RAY IMAGE RECEIVED THE MATERIAL MEASURED 6.5 MM X 1.48 MM. IT WAS REPORTED BY THE PHYSICIAN THAT THERE WAS A HIGH POSSIBILITY THAT THE FOREIGN MATTER WAS A PART OF A COMPETITOR'S PRODUCT, BUT REQUESTED EVALUATION OF THE ENVOY GUIDING CATHETER TO DETERMINE IF THERE IS ANY DAMAGE INSIDE OR OUTSIDE OF THE DEVICE. THERE WAS NO MISSING SECTION OF THE ENVOY CATHETER UPON REMOVAL. THE DEVICE WAS STORED PER LABELING INSTRUCTIONS AND WAS COPIOUSLY FLUSHED WITH SALINE DURING PREP. THERE IS NO FURTHER INFORMATION REGARDING THE PREPPING PROCEDURE OF THE DEVICES USED. THERE IS NO INFORMATION REGARDING THE CONTRAST USED. IT WAS REPORTED THAT NO DEBRIS WAS NOTED IN THE CONTRAST, SYRINGE OR INJECTOR. THE ENVOY WAS CONNECTED TO A FLUSH LINE WHICH WAS CHECKED FOR DEBRIS. IT IS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE ENVOY. THERE IS NO FURTHER INFORMATION AVAILABLE. ONE NON STERILE UNIT OF ENVOY 5F 056 STR WAS RECEIVED COILED IN AN UNKNOWN POUCH. BLOOD RESIDUES WERE FOUND IN THE INNER SIDE OF THE CATHETER. THE CATHETER EXTERNAL COMPONENTS (BODY SHAFT AND HUB) WERE VISUALLY INSPECTED USING A MICROSCOPE DEVICE AND NO DAMAGES/ANOMALIES OR MISSING PARTS WERE DETECTED. THE CATHETER WAS FLUSHED ACCORDING TO DP 12155047 IN ORDER TO VERIFY THE PART FOR FOREIGN MATERIALS INSIDE THE CATHETER AND NO FOREIGN MATERIALS WERE FOUND. THE CATHETER WAS CUT LENGTHWISE IN ORDER TO INSPECT THE INNER SIDE OF THE UNIT FOR DAMAGES AND/OR MISSING COATING (PTFE) AND NO MISSING COATING OR DAMAGES WERE OBSERVED THROUGHOUT THE CATHETER INNER LENGTH. THE INSPECTION WAS PERFORMED USING A MICROSCOPIC DEVICE. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH ANALYSIS OF THE RETURNED DEVICE IT COULD NOT BE CONFIRMED THAT THE FOREIGN MATERIAL WAS FROM THE ENVOY; NO COATING DAMAGES OR MISSING PARTS WERE OBSERVED ON ANY PART OF THE INTERNAL OR EXTERNAL CATHETER. CONTROLS ARE IN PLACE FOR INSPECTION OF THE CATHETER FOR THIS TYPE OF CONDITIONS; THE PRODUCED CATHETERS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. ALSO, SEVERAL INSPECTIONS ARE PERFORMED THROUGH ALL THE GUIDING CATHETER ASSEMBLY PROCESS OPERATIONS. BASED ON THE SIZE INDICATED ON THE RECEIVED IMAGE AND THE 1.4 MM ID OF THE 5 FR ENVOY, IT DOES NOT APPEAR THAT THE MATERIAL WOULD HAVE BEEN EXPRESSED FROM THE INNER LUMEN OF THE DEVICE. AS REPORTED, PROCEDURAL FACTORS INCLUDING CONCOMITANT DEVICES MAY HAVE CONTRIBUTED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THERE IS NO INDICATION OF ANY MANUFACTURING RELATED ISSUES BASED ON THE ANALYSIS OF THE RETURNED DEVICE AND DEVICE HISTORY RECORDS REVIEW. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15147095 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS OR EXCURSIONS WERE ISSUED FOR THIS LOT 15147095. THE FLUSHING MACHINE RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    WHEN THE ANGIOGRAPHY WAS PERFORMED, VERTEBRAL ARTERY WAS NOT SHOWN. NEXT, AORTIC ANGIOGRAPHY WAS PERFORMED BY USING ENVOY (B)(4)(COMPLAINT PRODUCT) AND VERTEBRAL ARTERY WAS CONFIRMED. NOTHING STRANGE WAS CONFIRMED AT THIS POINT. THEN, WHEN ANOTHER ANGIOGRAPHY WAS PERFORMED FOR VERTEBRAL ARTERY AND ENTIRE BRAIN BY USING ANGIOGRAPHY CATHETER (DETAIL UNKNOWN), FOREIGN MATTER WAS NOTED THROUGH THE IMAGE. ACCORDING TO THE PHYSICIAN, THERE IS A HIGH POSSIBILITY THAT THE FOREIGN MATTER WAS A PART OF COMPETITOR'S PRODUCT. IN CASE, PLEASE INVESTIGATE IF THERE IS ANY DAMAGE INSIDE AND OUTSIDE THE GUIDING CATHETER. THE PROCEDURE WAS THROMBOLYSIS: TARGET LESION WAS VERTEBRAL ARTERY. AFTER REMOVAL, THE CATHETER WAS NOT MISSING ANY SECTION. NO DEBRIS WAS NOTICED IN THE CONTRAST, SYRINGE OR INJECTOR. THE CATHETER WAS CONNECTED TO A FLUSH LINE, AND THE FLUSH LINE WAS CHECK FOR ANY DEBRIS. THE PRODUCT WAS STORE PER LABELING INSTRUCTIONS. DURING PREP, THIS CATHETER AND ALL CATHETERS WERE FLUSH COPIOUSLY WITH SALINE. THE CATHETER WAS NOT INSPECTED FOR DAMAGES. PRIOR TO INSERTING THE CORDIS CATHETER, AN ANGIOGRAM WAS NOT TAKING WITH THE NON-CORDIS CATHETER. THE ADMITTING DIAGNOSIS WAS THROMBOLYTIC TREATMENT FOR VERTEBRAL ARTERY. PRIOR TO SHIPPING, NO DAMAGES WERE NOTICED ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVOY 5F GUIDING CATHETERS CES GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO 15147095

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other