BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1133683 · Received August 20, 2008

    Report

    Report Number
    1016427-2008-00223
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THE ANGIOGUARD MIGRATION CLIPS CAME OFF DURING THE PREP OF THE DEVICE. THERE WAS NO SPECIFIC PATIENT, PROCEDURE OR TARGET LESION CHARACTERISTICS PROVIDED. THE DEVICE WAS HANDLED ACCORDING TO THE IFU (INSTRUCTIONS FOR USE). THE BOX AND PACKAGING WERE FREE OF ANOMALIES. THE SALES REPRESENTATIVE WAS IN THE ANGIO SUITE AT THE TIME OF THE PROCEDURE, HOWEVER HE WAS IN THE CINE ROOM NOT IN THE PROCEDURE ROOM AND WAS UNABLE TO CONFIRM THAT THE DEVICE WAS SECURE IN THE HOOP WHEN REMOVED FROM THE PACKAGE. THE TECH REMOVED THE TWO PROXIMAL MIGRATION CLIPS; HOWEVER, IT WAS INDICATED THAT THE THIRD MIGRATION CLIP CAME OFF PRIOR TO THAT STEP IN PREPARATION. THERE IS NO OTHER REPORT OF DAMAGE TO THE DEVICE. THE ANGIOGUARD WAS NOT USED CLINICALLY AND WAS RETURNED FOR ANALYSIS. CONFIRMED KINKS/BENDS IN THE GUIDEWIRE, COIL STRETCHED AND TORQUE DEVICE FRACTURED. PER REPORT: AS RECEIVED, THE SPECIMEN DOES NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) DOES NOT INDICATE ANY MANUFACTURING DEFECTS OR ANOMALIES. THE REPORTED PACKAGING LOT CONSISTS OF 206 UNITS, FINAL INSPECTION TESTED AND DETERMINED TO BE ACCEPTABLE FOR SHIPMENT BY LRM AND SHIPPED IN 2008. EXCEPT DAMAGE FOUND, THE SPECIMEN DEVICE AND SHEATH APPEAR VISUALLY AND DIMENSIONALLY CORRECT. BECAUSE NOTHING BEYOND THE SHEATHED SPECIMEN AND THE DAMAGED TORQUE DEVICE WERE PROVIDED, THERE IS NO WAY TO CONFIRM OR ADDRESS THE COMPLAINT OF "DURING PREP OF THE PRODUCT THE MIGRATION CLIP CAME OFF THE ANGIOGUARD. THE PRODUCT WAS NOT CLINICALLY USED" BEYOND THE STEPS DOCUMENTED. THE ANTI-MIGRATION DEVICES ARE INTENDED TO PREVENT MOVEMENT OF THE SPECIMEN DEVICE WITHIN THE DISPENSER ASSEMBLY DURING SHIPPING AND HANDLING; THE ANTI-MIGRATION DEVICES ARE INTENDED TO BE REMOVED FROM THE DISPENSER ASSEMBLY AS PART OF THE NORMAL PREPARATION OF THE ANGIOGUARD ECGW FOR CLINICAL USE. THE DAMAGE TO THE SHEATH APPEARS CONSISTENT WITH HAVE BEEN INCURRED DURING PREPARATION OF THE SHEATHED DEVICE. THE SHEATH SHAFT PRESENTS INDICATIONS OF OPENING ALONG THE PRESCORE SEEM 26.0 TO 29.4CM FROM THE DISTAL END OF THE SHEATH. THIS CAN OCCUR IF THE SPECIMEN IS HANDLED IN A MANNER THAT APPLIES COMPRESSIVE LOADS AXIALLY TO THE DEPLOYMENT SHEATH. DUE TO THE MANUFACTURED PRE-SCORE, THE COLUMN STRENGTH OF THE DELIVERY SHEATH IS INSUFFICIENT TO TRANSMIT THESE TYPES OF LOADS. THE BEND/KING DAMAGE TO THE WIRE SHAFT PROXIMAL OF THE FILTER IS NOT ADDRESSED IN THE COMPLAINT DOCUMENTATION; AS SUCH, CAUSE AND TIMING OF THE BEND/KINK DAMAGE CANNOT BE DETERMINED WITHOUT FURTHER INFORMATION. THE OVER-SEATED CONDITION OF THE SPECIMEN, AS RECEIVED, WILL INHIBIT DEPLOYMENT IN A NORMAL MANNER DURING A CLINICAL APPLICATION. THE NATURE OF THE DAMAGE TO THE RETURNED SPECIMEN AND THE INTERPRETATION OF THE COMPLAINT SUGGEST PROCEDURAL FACTORS AND LEVEL OF PRODUCT KNOWLEDGE IMPACTED ON THE EVENT AS REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS DOES NOT INDICATE ANY MANUFACTURING DEFECTS OR ANOMALIES. THESE OBSERVATIONS AND SPECULATIONS ARE BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE ARTICLE AND LIMITED INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION. THE COMPLAINT OF MIGRATION CLIP COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RECEIVED SPECIMEN. THE COMPLAINT DOES NOT ADDRESS THE OTHER DAMAGE REVEALED ON EXAMINATION. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE OF THE DEVICE.

    Description of Event or Problem · 1

    DURING PREP OF THE PRODUCT THE MIGRATION CLIP CAME OFF THE ANGIOGUARD. THE PRODUCT WAS NOT CLINICALLY USED. FURTHER INFORMATION INDICATED THE PACKAGING BOX WAS WITHOUT ANY ANOMALIES. HOWEVER, THERE WAS UNCERTAINTY IF THE DEVICE WAS SECURE IN THE HOOP WHEN IT WAS REMOVED FROM THE PACKAGING BOX. THE DEVICE WAS OPENED AND THE PREPARATION BEGAN. THE TECH REMOVED THE TWO PROXIMAL MIGRATION CLIPS; HOWEVER, IT WAS INDICATED THAT THIRD MIGRATION CLIP CAME OFF PRIOR TO THE STEP IN PREPARATION. THEREFORE, THIS EMBOLIC PROTECTION GUIDEWIRE SYSTEM WAS NOT CLINICALLY USED. THE DEVICE WAS RECEIVED FOR ANALYSIS AND AFTER REVIEW, BASED ON VISUAL ANALYSIS, STRETCHED COIL WAS IDENTIFIED. THEREFORE, THIS FILE WAS REDETERMINED TO BE REPORTABLE BASED ON SIGNIFICANT ANALYSIS FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70108529

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK