BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 1011791 · Received March 11, 2008

    Report

    Report Number
    1016427-2008-00063
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE 4F DILATATION CATHETER WAS INTRODUCED OVER THE GW, THE CATHETER WAS UNABLE TO ADVANCE OVER THE WELDED PART OF THE GW. THEREFORE THE GUIDEWIRE WAS REMOVED AND ATTEMPTS WERE MADE TO USE ANOTHER SV-5 GW, HOWEVER, THIS GW WAS ALSO REPORTED TO HAVE THE SAME ISSUE. THEREAFTER A V-18 GW WAS USE ABLING TO BRING THE DILATATION CATHETER OVER THE GW AND PERFORMED THE ANGIOPLASTY. BOTH SV-5 GW WERE REMOVED INTACT IN ONE PIECE WITHOUT ADVERSE CONSEQUENCE TO THE PATIENT. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT YET COMPLETED. ADDITIONAL INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED DURING A PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY, A GAP WAS NOTICED BETWEEN THE GUIDEWIRE'S COILING TIP SECTION AND THE BODY OF THE GUIDEWIRE. THERE WERE NO ANOMALIES NOTED DURING PRODUCT'S INSPECTION AND PREPARATION. THE DEVICE WAS USE ACCORDING TO INSTRUCTION FOR USE (IFU) AND ITS SPECS. THE INTENDED PROCEDURE WAS AN ANGIOPLASTY OF THE LEFT RENAL ARTERY WITH IN-STENT STENOSIS. THERE IS NO INFO REGARDING THE STENT. THE TARGET LESION MEASURED (30 X 5) MM (LENGTH X REFERENCE VESSEL DIAMETER) WITH A 90% STENOSIS. THERE WAS NO CALCIFICATION OR TORTUOSITY REPORTED. SOME DIFFICULTY TRACKING THE GUIDEWIRE THROUGH THE VESSEL TOWARDS THE LESION WAS INDICATED. THE GUIDEWIRE (GW) WAS WITHOUT KINKS AND WAS NOT ADVANCED THROUGH THE STRUTS OF THE EXISTING STENT. THE TIP WAS NOT PROLAPSED DURING USE, WAS NOT TORQUED AGAINST RESISTANCE NOR WAS JAILED BEHIND A STENT. THERE WAS NO RESISTANCE REPORTED BETWEEN THE GW AND OTHER DEVICES THAT WERE USED IN COMBINATION EXCEPT WHEN WITHDRAWING THE SELECTIVE DIAGNOSTIC CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70407771

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR V-18 GUIDEWIRE (BSC)| CATHETER (BSC)| SV-5 GUIDEWIRE (CORDIS)| 4F PTA BALLOON STERLING 5/40MM DILATATION| SOS-OMNI SELECTIVE CATHETER (ANGIODYNAMICS)