BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 8MM X 30MM, 135 CM

    MDR report key: 7236945 · Received February 2, 2018

    Report

    Report Number
    9616099-2018-01823
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 15, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED BUT THE ENGINEERING REPORT IS PENDING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE DEVICE WAS NOT USED IN THE PATIENT. THIS DEVICE IS NOT SOLD IN THE US BUT IS IT SIMILAR TO THE PRECISE PRO RX STENT THAT IS SOLD IN THE US UNDER PMA#P030047.

    Additional Manufacturer Narrative · 1

    AFTER AN 8MMX30MM PRECISE PRO RX STENT WAS REMOVED THE PACKAGING AND FLUSHED, THE STENT WAS FOUND TO BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED IN THE TRAY. THE TUOHY BORST (HEMOSTASIS) ¿HUNG SLACK¿ WHEN RECEIVED. WHEN REMOVED FROM THE TRAY WAS THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STOPCOCK AND NO DIFFICULTY ENCOUNTERED FLUSHING THE SDS. ONE NON-STERILE PRECISE PRO RX 8X30 WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE UNIT WAS RECEIVED WITH THE HEMOSTASIS VALVE OPENED, WITH THE STENT FULLY DEPLOYED AND THE STENT OF THE UNIT WAS NOT RECEIVED FOR ANALYSIS (SEE ATTACHED PICTURES), NO BLOOD RESIDUES WERE FOUND ON THE RECEIVED DEVICE. NO OTHER ANOMALIES DAMAGES WERE FOUND ON THE RECEIVED DEVICE. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17633751 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE FAILURE REPORTED BY THE CUSTOMER ¿STENT DELIVERY SYSTEM (SDS)-SES - DEPLOYMENT DIFFICULTY - PREMATURE DEPLOYMENT¿ WAS CONFIRMED SINCE THE UNIT WAS RECEIVED WITH THE STENT FULLY DEPLOYED AND WITHOUT BLOOD RESIDUES FOUND. THE CAUSE OF THE DEPLOYMENT DIFFICULTY - PREMATURE DEPLOYMENT REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT INFORMATION FOR SAFETY WARNS ¿AFTER CAREFUL INSPECTION OF THE POUCH LOOKING FOR DAMAGE TO THE STERILE BARRIER, CAREFULLY PEEL OPEN THE POUCH AND EXTRACT THE STENT DELIVERY SYSTEM FROM THE TRAY. EXAMINE THE DEVICE FOR ANY DAMAGE. IF IT IS SUSPECTED THAT THE STERILITY OR PERFORMANCE OF THE DEVICE HAS BEEN COMPROMISED, THE DEVICE SHOULD NOT BE USED. EVALUATE THE DISTAL END OF THE CATHETER TO ENSURE THAT THE STENT IS CONTAINED WITHIN THE OUTER SHEATH. DO NOT USE IF THE STENT IS PARTIALLY DEPLOYED¿. NEITHER THE DEVICE HISTORY RECORD NOR THE PRODUCT ANALYSIS SUGGEST THAT THE EVENT COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AFTER AN 8X30 PRECISE PRO RX STENT WAS REMOVED THE PACKAGING AND FLUSHED, THE STENT WAS FOUND TO BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78744 PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 8MM X 30MM, 135 CM SELF EXPANDING STENT NIM CORDIS CORPORATION N/A 17633751

    Patients

    Seq Age Sex Outcome Treatment
    1