BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2924649 · Received January 22, 2013

    Report

    Report Number
    9616099-2013-00029
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A CAROTID STENTING PROCEDURE THE SDS WAS VERY DIFFICULT TO REMOVE OVER THE ANGIOGUARD AFTER DEPLOYMENT OF A PRECISE PRO RX STENT. IT WAS NOTED THAT AN EXTREME AMOUNT OF FORCE WAS USED TO REMOVE THE DEVICE. ALSO, WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE ANGIOGUARD, THE RETRIEVAL CATHETER WOULD NOT TRACK OVER THE WIRE. THE ANGIOGUARD GUARD WAS REMOVED FROM THE PATIENT WITHOUT BEING RE-SHEATHED INTO THE RETRIEVAL CATHETER. ANALYSIS OF THE RETURNED SDS NOTED THAT THE DISTAL TIP WAS SEPARATED. ONE NON-STERILE PRECISE PRO RX US CAROTID SYST 6 X 30MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. UNIT WAS DEPLOYED. UNKNOWN STOPCOCK WAS RECEIVED ATTACHED TO THE HUB. OUTER MEMBER WAS COMPRESSED AT 15.5CM FROM BRITE TIP. THE DISTAL END OF THE INNER BODY WAS SEPARATED 1.2CM FROM THE STOP, AND LOOKS COMPRESSED. DISTAL TIP WAS NOT RECEIVED. A GUIDE WIRE 0.014" WAS INTRODUCED THROUGH THE WIRE LUMEN AND NO RESISTANCE/FRICTION WAS FELT. SEM RESULTS SHOWED THAT THE CATHETER'S BODY PRESENTED EVIDENCE OF ELONGATION. IN ADDITION, THE BRAID WIRE PRESENTED EVIDENCE OF DUCTILE DIMPLES. STRETCHING AND/ OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING WAS DISCARDED AS A ROOT CAUSE SINCE NO CUTTING CHARACTERISTICS WERE OBSERVED IN THE BODY OF THE CATHETER AND/OR IN THE BRAID WIRE. IT WAS NOT POSSIBLE TO CONCLUSIVELY DETERMINE WHAT CAUSED THE FLATTENED SECTIONS. THE CAUSE OF THE INNER BODY SEPARATED COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO DETECT THESE KIND OF ISSUES. HANDLING AND PROCEDURAL FACTORS COULD BE CONTRIBUTED TO THIS CONDITION; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MOREOVER, ACCORDING TO THE RECEIVED CONDITIONS, IT APPEARS THAT THE ANGIOGUARD WAS ATTEMPTED TO BE RECAPTURED ON THE PRECISE PRO RX, THEREFORE, THE PRECISE PRO RX GOT STUCK IN THE PROXIMAL MARKER BAND OF THE ANGIOGUARD, IT IS POSSIBLE THAT THE DRIED BLOOD RESIDUES ALSO INFLUENCED ON THIS EVENT. IT IS IMPORTANT TO MENTION THAT THE ANGIOGUARD INSTRUCTIONS FOR USE STATE THAT THE CAPTURE SHEATH MUST BE USED TO RECAPTURE THE ANGIOGUARD. ACCORDING TO THE EVENT DESCRIPTION, IT IS POSSIBLE THAT THE PRECISE PRO RX WAS SEPARATED DUE TO THE EXTREME AMOUNT OF FORCE USED TO REMOVE IT. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT AS REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY DEVICE INTERACTION AND PROCEDURAL FACTORS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A CAROTID STENTING PROCEDURE, THE CATHETER WAS VERY DIFFICULT TO REMOVE OVER THE 5MM ANGIOGUARD WIRE AFTER DEPLOYMENT OF A PRECISE PRO RX STENT. IT WAS NOTED THAT EXTREME AMOUNT OF FORCE WAS USED TO REMOVE THE DEVICE. ALSO, WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE ANGIOGUARD THE RETRIEVAL CATHETER WOULD NOT TRACK OVER THE WIRE. THE ANGIOGUARD GUARD WAS REMOVED FROM PATIENT WITHOUT BEING RE-SHEATHED IN RETRIEVAL CATHETER. SIGNIFICANT FINDINGS WERE NOTED UPON THE PRECISE STENT PRODUCT RETURNED, DISTAL TIP WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30085 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15667714

    Patients

    Seq Age Sex Outcome Treatment
    1