BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1170697 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02261
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    CORDIS DE MEXICO,
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE PRECISE OTW 10X40 MM WAS RECEIVED. THE SHAFT HAD A KINK; THE RADIOPAQUE MARKER WAS SPLIT AND HAD BLOOD RESIDUES. THE SPLIT APPEARED TO BE CAUSED BY THE DISTAL TIP BEING OVER CANNULATED. THE HUB WAS CRACKED, AS WELL AS THE FLUSHING SECTION OF THE HEMOSTASIS VALVE, WHICH HAD AN UNKNOWN STOPCOCK ATTACHED TO IT. NO OTHER ANOMALY WAS OBSERVED ON THE RECEIVED UNIT. THE OUTER DIAMETER OF THE OUTER SHEATH AND THE DISTAL TIP WERE MEASURED AND WERE FOUND WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE REPORTED TRACKING DIFFICULTY COULD NOT BE CONFIRMED. THE REPORTED DAMAGE ON THE TIP WAS CONFIRMED, HOWEVER, THE EXACT CAUSE OF THE DAMAGE, AS WELL AS THE CAUSE OF THE KINK ON THE SHAFT, COULD NOT BE CONCLUSIVELY DETERMINED. IT IS LIKELY THAT PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS CONTRIBUTED; THE DAMAGES COULD HAVE OCCURRED DURING THE ATTEMPTS TO DELIVER THE STENT INTO THE LESION. PER THE REPORT FROM THE ACCOUNT THE ONLY DAMAGE REPORTED WAS TO THE TIP OF THE SDS. THE ADDITIONAL DAMAGE FOUND DURING PRODUCT ANALYSIS WAS NOT DESCRIBED BY THE ACCOUNT. IT IS UNKNOWN WHEN OR WHERE THIS DAMAGE OCCURRED. WITH THE INFO PROVIDED IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE HUB CRACK.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED RESISTANCE WAS PRESENT DURING ADVANCEMENT OF THE PRECISE OTW STENT DELIVERY SYSTEM (SDS) TOWARDS THE LESION. THE INTENDED TARGET SITE WAS THE LEFT INTERNAL CAROTID ARTERY DESCRIBED AS HAVING MILD CALCIFICATION AND VESSEL TORTUOSITY WITH A 95% STENOSIS. APPROXIMATELY 2CM PROXIMAL TO THE TARGET THE DEVICE WAS UNABLE TO FURTHER ADVANCE. THE DEVICE WAS RETRIEVED AND THE TIP WAS NOTED TO BE DAMAGED. THERE WAS NO SEPARATION OF ANY PART OF THE PRODUCT. THERE WERE NO ANOMALIES WITH THE DEVICE FOUND DURING INSPECTION. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO, NA 13326741

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR SHEATH: COOK| ANGIOGUARD (CAT/LOT UNKNOWN)