BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSIT MICROCATHETERS

    MDR report key: 1834229 · Received September 14, 2010

    Report

    Report Number
    1058196-2010-00269
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A (PTCA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE HUB OF THE TRANSIT MICROCATHETER (600-330) BROKE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW PRODUCT WITHOUT ANY PATIENT INJURY. THE MICROCATHETER WAS USED FOR SUPPORTING THE UNKNOWN GUIDEWIRE. THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THERE WAS NO INFORMATION ABOUT THE PATIENT'S GENDER AND AGE. ACCESS SITE WAS FEMORAL ARTERY. THE PRODUCT WAS PREP PRIOR TO USE, AND NO DAMAGES WERE NOTICED DURING PREP, INCLUDING THE HUB. DURING PREP, A SYRINGE WAS CONNECTED TO THE HUB WITHOUT ANY PROBLEMS, AND THE PRODUCT WAS ABLE TO BE FLUSHED. NO OTHER DAMAGES WERE NOTICED WITH THE DEVICE, SHAFT, OR HUB, ETC. THE PRODUCT WAS NEW, AND IT WAS STORE PER LABELING INSTRUCTIONS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A NON-STERILE TRANSIT MICROCATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE PRODUCT WAS INSPECTED AND FLAT/TWISTED SECTIONS WERE FOUND ON DISTAL END. THE HUB WAS INSPECTED AND A CRACK WAS FOUND ON IT. THE MICROCATHETER WAS INSPECTED UNDER MICROSCOPE AND FLAT/TWISTED SECTIONS WERE CONFIRMED, AS WELL AS THE CRACKED HUB. THE CAUSE OF FLAT/TWISTED SECTIONS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER INSPECTIONS ARE IN PLACE TO PREVENT THIS KIND OF FAILURE LEAVING FROM THE FACILITY; POST PROCEDURAL HANDLING FOR RETURN MAY HAVE CONTRIBUTED. THE DEVICE WAS FLUSHED WITH A LAB SAMPLE SYRINGE AND A LEAK WAS OBSERVED IN THE HUB IN THE CRACKED AREA. SCANNING ELECTRON MICROSCOPIC ANALYSIS WAS PERFORMED. MULTIPLE CRACKS COULD BE NOTED IN THE EXTERNAL SURFACE OF THIS PIECE ALONG WITH THE CRAZES THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE HUB. SOME OF THE FRACTURE SURFACES OF THE HUB EXHIBIT AREAS THAT ARE BRITTLE IN APPEARANCE. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. THE EXACT CAUSE OF THIS CRACKING COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THERE WAS NO DAMAGES NOTED DURING FLUSHING WITH PREP. IT IS POSSIBLE THAT PROCEDURAL FACTORS AND FIT WITH CONCOMITANT DEVICES MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, NO CONCLUSION CAN BE MADE. THE REPORTED BROKEN HUB WAS CONFIRMED. THE CAUSE OF THE CRACKS IS UNDETERMINED. THIS TYPE OF ISSUE HAS BEEN EVALUATED VIA THE RISK MANAGEMENT PROCESS FOR INVESTIGATION. ACTION WAS PREVIOUSLY OPENED TO ADDRESS THIS KIND OF ISSUE. THIS ADDITIONAL COMPLAINT DOES NOT CHANGE THE SEVERITY OR OCCURRENCE AS DOCUMENTED IN THE ACTION AND NO ROOT CAUSE HAS BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15037910 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. PROCESS MONITORING REVEALED NO EXCURSIONS WERE FOUND FOR LOT 15037910. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. CALIBRATION RECORDS FOR SEAL MACHINE WITH CALIBRATION WAS REVIEWED, AND IT WAS FOUND THAT THE EQUIPMENT WAS CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATES. PREVENTIVE MAINTENANCE RECORDS FOR SEAL MACHINE WAS REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A (PTCA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE HUB OF THE MICROCATHETER 600-330 BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED USING OTHER NEW PRODUCT WITHOUT ANY PATIENT INJURY. THE MICROCATHETER WAS USED FOR SUPPORTING THE GUIDEWIRE (DETAIL UNKNOWN). THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THERE WAS NO INFORMATION ABOUT THE PATIENT'S GENDER AND AGE. ACCESS SITE WAS FEMORAL ARTERY. THE PRODUCT WAS PREP PRIOR TO USE, AND NO DAMAGES WERE NOTICED DURING PREP, SPECIALLY THE HUB. DURING PREP, A SYRINGE WAS CONNECTED TO THE HUB WITHOUT ANY PROBLEMS, AND THE PRODUCT WAS ABLE TO BE FLUSHED. NO OTHER DAMAGES WERE NOTICED WITH THE DEVICE, SHAFT, OR HUB, ETC. THE PRODUCT WAS NEW, AND IT WAS STORE PER LABELING INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSIT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. 15037910

    Patients

    Seq Age Sex Outcome Treatment
    1