BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1079394 · Received July 17, 2008

    Report

    Report Number
    1016427-2008-00198
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 28, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THE ANGIOGUARD DISTAL EMBOLIC PROTECTION DEVICE WAS KINKED WHEN REMOVED FROM THE PACKAGE. ADDITIONAL INFORMATION RECEIVED INDICATED THE PEEL AWAY PORTION WAS ALREADY STARTING TO PEEL WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THERE WERE NO VISIBLE ANOMALIES WITH THE PACKAGING. THE PRODUCT WAS NOT CLINICALLY USED. THERE WAS NO REPORTED INJURY FOR THE PATIENT AND NO PATIENT, VESSEL/LESION OR PROCEDURAL DETAILS WERE PROVIDED. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS RECEIVED, THE SPECIMEN DOES NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. THE SPECIMEN DEVICE AND SHEATH APPEAR VISUALLY AND DIMENSIONALLY CORRECT. THE DAMAGE TO THE SHEATH APPEARS CONSISTENT WITH BEING INCURRED DURING PREPARATION OF THE SHEATHED DEVICE. THE SHEATH SHAFT PRESENTS INDICATIONS OF OPENING ALONG THE PRESCORE SEAM 26.0 TO 29.4CM FROM THE DISTAL END OF THE SHEATH. THIS CAN OCCUR IF THE SPECIMEN IS HANDLED IN A MANNER THAT APPLIES COMPRESSIVE LOADS AXIALLY TO THE DEPLOYMENT SHEATH, THE COLUMN STRENGTH OF THE DELIVERY SHEATH IS INSUFFICIENT TO TRANSMIT THESE TYPES OF LOADS. A REVIEW OF THE DEVICE HISTORY RECORDS (DHA) DOES NOT INDICATE ANY MANUFACTURING DEFECTS OR ANOMALIES. THE REPORTED PACKAGING LOT WAS FINAL INSPECTION TESTED AND DETERMINED TO BE ACCEPTABLE FOR SHIPMENT. THE COMPLAINT OF SHEATH PEELING WAS CONFIRMED. HOWEVER, THE ADDITIONAL DAMAGED FOUND UPON INSPECTION COULD NOT BE ADDRESSED BY THE CUSTOMER. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. BASED ON THE LIMITED INFORMATION AND THE CONDITION OF THE RECEIVED PRODUCT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION REGARDING A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THERE ARE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT UPON REMOVING THE ANGIOGUARD RX FROM THE PACKAGE, THE WIRE WAS FOUND KINK, THE PEEL AWAY PORTION OF THE WIRE WAS ALREADY PEELING AWAY IN THE MIDDLE OF THE TWO SEGMENTS; AS A RESULT, THE PRODUCT WAS NOT USED IN THE PATIENT. THE PRODUCT PACKAGE DID NOT PRESENT ANY ANOMALIES. THE PRODUCT WAS RETUNED FOR EVALUATION; HOWEVER, THE ANALYSIS IDENTIFIED THE COIL WAS STRETCHED AND THE POLYTETRAFLUOROETHYLENE (PTFE) WAS FOUND SCRAPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71107506

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK