BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 1181704 · Received September 30, 2008

    Report

    Report Number
    1016427-2008-00252
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    May 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PERIPHERAL INTERVENTION, A STEERABLE GUIDEWIRE BECAME STUCK IN THE GUIDEWIRE LUMEN OF AN UNK STENT DELIVERY SYSTEM. THE WIRE AND SDS WERE REMOVED AS A UNIT FROM THE PT AND NO INJURY OCCURRED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO WERE UNSUCCESSFUL. ANALYSIS OF THE RETURNED WIRE CONFIRMED BENDS IN THE GUIDEWIRE, AS WELL AS STRETCHED COILS. AS RECEIVED, THE SPECIMEN DOES NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY. THE JOINTS APPEAR INTACT AND CORRECT WHEN VIEWED AT 18" WITH VISION CORRECTED TO 20-20 AND AT 10X MAGNIFIED. EXAMINATION OF THE DISTAL REGION OF THE BALLOON CATHETER REVEALS THE PRESENCE OF A DARK MASS WITHIN THE CATHETER LUMEN CAUSING A PARTIAL OCCLUSION. THIS MASS IS OBSERVED TO MOVE WITHIN THE LUMEN WITH AXIAL MOVEMENT OF THE WIRE SHIFT. PRIOR TO ATTEMPTING TO REMOVE THE SPECIMEN WIRE FROM THE BALLOON CATHETER BY WITHDRAWAL OF THE WIRE, THE COIL SEGMENT PRESENTS NO DAMAGE OR ANOMALIES ASIDE FROM THE BEND LOCATED 0.95 TO 2.50CM FROM THE DISTAL TIP. DURING THE ATTEMPT TO WITHDRAW THE SPECIMEN WIRE FROM THE BALLOON CATHETER, SOME RESISTANCE WAS NOTED WHEN THE PROXIMAL LIMIT OF THE COIL WAS APPROXIMATELY 3MM DISTAL OF THE PROXIMAL SIDE OPENING OF THE BALLOON CATHETER. AFTER REMOVAL FROM THE BALLOON CATHETER BY WITHDRAWING THE WIRE PROXIMALLY THROUGH THE CATHETER LUMEN, THE COILING WIRE IS STRETCHED FROM THE INTACT PROXIMAL JOINT; INDICATIVE OF A CONSTRAINT CONDITION, LIKELY CAUSED BY THE PREVIOUSLY NOTED MASS. ALSO PRESENT IN THE STRETCHED COIL WRAPS AND IN THE PROXIMAL SIDE PORT OF THE BALLOON CATHETER IS DRIED BIOMATERIAL THAT LIKELY CAUSED SOME DEGREE OF OCCLUSION WITHIN THE LUMEN OF THE CATHETER. A REVIEW OF THE DEVICE HISTORY FOR THIS SPECIMEN INDICATES THIS LOT WAS FINAL INSPECTION TESTED AND DEEMED ACCEPTABLE FOR SHIPMENT. THE COMPLAINT WAS CONFIRMED. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE ARE NO INDICATIONS THAT THIS EVENT IS RELATED TO THE MFR OF THE WIRE.

    Description of Event or Problem · 1

    AN SV GUIDEWIRE BECAME "BLOCK" IN THE STENT. THE PHYSICIAN REMOVED THE STENT AND THE GUIDEWIRE FROM THE PT. THERE WAS NO PT INJURY REPORTED. PER THE ANALYSIS FINDINGS, THE GUIDEWIRE HAD STRETCHED COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 71107710

    Patients

    Seq Age Sex Outcome Treatment
    1