BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 1244825 · Received November 20, 2008

    Report

    Report Number
    1016427-2008-00296
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, ANALYSIS HAS NOT BEGUN. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO THE RIGHT VERTEBRAL ARTERY, THERE WAS DIFFICULTY EXPERIENCED ADVANCING THE POWERFLEX P3 THROUGH THE TORTUOUS VESSEL. THE PRODUCT WAS DELIVERED OVER A 0.035 RADIFOCUS, TERUMO GUIDEWIRE. A PGW .018 SV SHORT WIRE WAS INSERTED INTO THE 7F SHUTTLE SHEATH TO SUPPORT THE RADIFOCUS WIRE AS A BUDDY WIRE; HOWEVER, THERE WAS FRICTION ENCOUNTERED BETWEEN THE BALLOON SHAFT OF THE POWERFLEX P3 BECAUSE OF THE TORTUOUS VESSEL SHAPE AND THE TIP OF THE WIRE KINKED AND BECAME SPIRAL SHAPED. HOWEVER, THE WIRE WAS ADVANCED PAST THE DISTAL END OF THE SHEATH AS IT WAS AND THE WIRE TIP BECAME MORE SPIRALED AND WINDED. THE PGW .018 SV SHORT WIRE BECAME STUCK AND COULD NOT BE RETRIEVED FROM THE SHEATH. THE SHEATH WAS EVENTUALLY REMOVED FROM THE PATIENT AND THE PGW .018 SV SHORT GUIDEWIRE WAS REMOVED BY CUTTING AWAY A PORTION OF THE SPIRAL TIP. THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES AND A COMPETITOR'S STENT WAS PLACED IN THE TARGET LESION. THERE WERE NO ADVERSE EVENT TO THE MALE PATIENT AND HE IS IN STABLE CONDITION. THE TARGET VESSEL WAS MODERATELY CALCIFIED AND HEAVILY TORTUOUS WITH 90% STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70608813

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR STENT: P2006E| SHEATH: 7F SHUTTLE SHEATH| GW: 0.035 RADIFOCUS (TERUMO)