BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1231144 · Received November 12, 2008

    Report

    Report Number
    1016427-2008-00288
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED STATES THE ANGIOGUARD DISTAL PROTECTION DEVICE HAD OUTER PACKAGE DAMAGE, AND WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING THE DEPLOYMENT SHEATH WAS KINKED PRIOR TO USE. WHEN THE PRODUCT WAS RETURNED IT WAS ALSO NOTED THAT THE PTFE COATING WAS FRAYED/SPLIT/TORN. THE DEVICE WAS NOT USED CLINICALLY; ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PRODUCT WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION, BENDS/KINKS WERE FOUND ON THE PRODUCT AND ADDITIONALLY THE PTFE COATING WAS SCRATCHED. THE LOCKING COLLAR OF THE TORQUE DEVICE IS FRACTURED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) INDICATES THIS PACKAGING LOT CONSISTS OF 70 UNITS, FROM TWO ASSEMBLY LOTS, FINAL INSPECTION TESTED AND DEEMED ACCEPTABLE FOR SHIPMENT. AS RECEIVED, THE SPECIMEN PRESENTS NO INDICATIONS OF MANUFACTURING DEFECTS OR ANOMALIES. EXCEPT FOR THE BEND/KINK DAMAGE TO THE SPECIMEN DEVICE AT 1.05 TO 3.90CM, 12.40 TO 261.6CM, 266.8 TO 268.0CM, 268.2 TO 274.1CM, 278.5CM AND 291.3 TO 298.8CM FROM THE DISTAL TIP AND THE DISTORTION CONSISTENT WITH AXIAL COMPRESSION LOCATED 0.95CM TO 1.05CM FROM THE DISTAL TIP OF THE SHEATH, THE SPECIMEN DEVICE AND SHEATH APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE DEPLOYMENT SHEATH PRESENTS NO OBVIOUS MANUFACTURING DEFECTS OR ANOMALIES. ALL JOINTS APPEAR TO BE INTACT BY NON-DESTRUCTIVE PULL TESTING. THE AS-RECEIVED CONDITION OF THE SPECIMEN EFFECTIVELY PREVENTS CONFIRMATION OF THE PACKAGING RELATED ASPECTS OF THE COMPLAINT. THE DAMAGE TO THE TORQUE DEVICE IMPLIES AN ATTEMPT WAS MADE TO PREP THE SPECIMEN DEVICE FOR USE. IT IS POSSIBLE THAT THE REPORTED DAMAGE TO THE SHEATH WAS INCURRED DURING THE PREPARATION ATTEMPT. THE SEATING OF THE FILTER WITHIN THE DELIVERY SHEATH IS VERY DEPENDENT ON POSITIONING OF THE SHEATH AND MAINTAINING THAT POSITION. THE DAMAGE TO THE WIRE SHAFT IS NOT DISCUSSED IN THE COMPLAINT DOCUMENTATION, BUT APPEARS TO HAVE BEEN INCURRED DURING HANDLING SUBSEQUENT TO REMOVAL FROM THE ORIGINAL PACKAGING POUCH. THE COMPLAINT OF OUTER PACKAGE DAMAGE COULD NOT BE CONFIRMED DUE TO THE AS-RECEIVED CONDITION OF THE DEVICE. THE COMPLAINT OF DEPLOYMENT SHEATH KINK WAS CONFIRMED. ADDITIONAL DAMAGE WAS NOTED BOTH ON THE INITIAL INSPECTION AND DURING FAL ANALYSIS. THE PTFE COATING WAS "SCRAPPED" OR FRAYED/SPLIT/TORN AND THE TORQUE DEVICE WAS FRACTURED. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT HANDLING AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT WHEN THE PHYSICIAN OPENED THE PACKAGE OF THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM, THE TIP OF THE DEPLOYMENT SHEATH WAS KINKED. ANOTHER PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED. THE OUTER BOX OF THE DEVICE WAS ALSO DEFORMED. THE ANGIOGUARD WAS RETURNED FOR EVALUATION, THE PRODUCT ANALYSIS REPORT IDENTIFIED THAT THE PTFE COATING WAS SCRATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70107508

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR