BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX US CAROTID SYST

    MDR report key: 7973237 · Received October 17, 2018

    Report

    Report Number
    9616099-2018-02447
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    July 13, 2018
    Report Date
    October 17, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    NIM
    UDI-DI
    20705032036488
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(4). DURING AN UNKNOWN PROCEDURE. AN 8X30 PRECISE PRO RX US CAROTID SYSTEM DID NOT CROSS THE LESION. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS. A NON-STERILE PRECISE PRO RX US CAROTID SYSTEM WAS RECEIVED FOR ANALYSIS. PER VISUAL INSPECTION, THE STENT WAS PARTIALLY DEPLOYED. NO OTHER DAMAGES OR ANOMALIES WERE DETECTED. PER DIMENSIONAL ANALYSIS, THE OUTER DIAMETER (OD) MEASUREMENTS WERE TAKEN AT THREE DIFFERENT PLACES AND WERE FOUND WITHIN SPECIFICATION. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE NATURE OF THE EVENT. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17656553 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE PHR REVIEW DOES NOT SUGGEST THAT THE EVENT REPORTED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THE EVENT REPORTED BY THE CUSTOMER AS ¿STENT DELIVERY SYSTEM - FAILURE TO CROSS" COULD NOT BE CONFIRMED DUE TO THE NATURE OF THE EVENT AND THE RELATIONSHIP TO THE DEVICE. THE DIMENSIONAL ANALYSIS RESULTS WERE FOUND WITHIN SPECIFICATION. ANALYSIS OF THE RETURNED DEVICE INDICATED THE STENT WAS PARTIALLY DEPLOYED. THE EVENT IDENTIFIED BY FAL ANALYSIS AS ¿STENT DELIVERY SYSTEM (SDS)-SES DEPLOYMENT DIFFICULTY - PREMATURE DEPLOYMENT¿ WAS DETERMINED VIA VISUAL ANALYSIS. PER THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿IF RESISTANCE IS MET DURING DELIVERY SYSTEM INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN, AND ANOTHER SYSTEM SHOULD BE USED. IF ANY RESISTANCE IS MET DURING DELIVERY SYSTEM WITHDRAWAL, ADVANCE THE OUTER SHEATH UNTIL THE MARKER CONTACTS THE CATHETER TIP AND WITHDRAW THE SYSTEM AS ONE UNIT. THE EXACT CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVE DETERMINED. HOWEVER, PROCEDURAL AND HANDLING FACTORS SUCH AS THE APPLICATION OF EXCESSIVE FORCE, AS WELL AS VESSEL CHARACTERISTICS, WHILE UNKNOWN, MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. PER THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿PRECISE® PRO RX NITINOL STENT SYSTEM IS SHIPPED WITH THE TUOHY BORST VALVE IN THE OPEN POSITION. CARE SHOULD BE TAKEN NOT TO PRE-DEPLOY THE STENT. THE DEVICE SHOULD BE PREPPED IN THE TRAY. AFTER PREP, EXTRACT THE STENT DELIVERY SYSTEM FROM THE TRAY. EXAMINE THE DEVICE FOR ANY DAMAGE. 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. IF A GAP BETWEEN THE CATHETER TIP AND OUTER SHEATH TIP EXISTS, OPEN THE TUOHY BORST VALVE AND GENTLY PULL THE INNER SHAFT IN A PROXIMAL DIRECTION UNTIL THE GAP IS CLOSED. LOCK THE TUOHY BORST VALVE AFTER THE ADJUSTMENT BY ROTATING THE PROXIMAL VALVE END IN A CLOCKWISE DIRECTION.¿ NEITHER THE PRODUCT ANALYSIS NOR THE PHR REVIEW SUGGESTS THAT THE EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AN 8X30 PRECISE RX SELF EXPANDING STENT DID NOT. CROSS THE LESION. THERE WAS NO PATIENT INJURY. ANALYSIS OF THE RETURNED DEVICE INDICATED THE STENT WAS PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814236 PRECISE PRO RX US CAROTID SYST SELF EXPANDABLE STENT NIM CORDIS CASHEL N/A 17656553 20705032036488

    Patients

    Seq Age Sex Outcome Treatment
    1