BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE SET

    MDR report key: 2062594 · Received April 8, 2011

    Report

    Report Number
    1820334-2011-00185
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PORTION OF DEVICE REMAINING IN PT. DEVICE SEPARATION IS DEMONSTRATED ON THE SCOR. THE WIREGUIDE WAS ALL THAT WAS KEPT AND PROVIDED FOR THE INVESTIGATION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. IN ADDITION, EACH PMG WIRE GUIDE COMES WITH AN ATTACHED CAUTION LABEL, WHICH ILLUSTRATES; "WITHDRAWAL AND/OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP MAY RESULT IN BREAKAGE." WITHOUT THE COMPLAINT DEVICE, WE CANNOT MAKE A DEFINITE ROOT CAUSE ANALYSIS. WHEN WE HAVE SEEN THIS TYPE OF DEVICE FAILURE IN THE PAST, IT HAS GENERALLY BEEN ASSOCIATED WITH THE WIRE GUIDE BEING DAMAGED BY WITHDRAWAL THROUGH THE NEEDLE (SEE WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPEC. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTIONS ARE REQUIRED AT THIS TIME AS THERE IS INSUFFICIENT RISK.

    Description of Event or Problem · 1

    DURING PTCD PROCEDURE, THE PHYSICIAN PUNCTURED UNDER ULTRASONIC ECHO AND CONFIRMED BILE DRAINAGE. AFTER ANGIOGRAPHY, HE INSERTED THE WIREGUIDE AND THE DILATOR OVER THE WIREGUIDE, BUT COULD NOT COMPLETE INSERTION BECAUSE RESISTANCE WAS MET. WHILE HE WAS WITHDRAWING THE DILATOR AND THE WIREGUIDE, HE FOUND THE WIREGUIDE BECAME UNRAVELED. HE CAREFULLY REMOVED THE WHOLE WIREGUIDE OUTSIDE OF THE PT, AND CONFIRMED ITS TIP WAS SEPARATED AND APPROX 1CM OF THE WIRE GUIDE TIP REMAINED IN THE INTRAHEPATIC BILE DUCT. ANOTHER LOT WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN DID NOT PERFORM ADD'L PROCEDURE FOR REMOVAL OF THE REMAINED WIREGUIDE AND WILL FOLLOW THE PT CLOSELY. THE PT HAS NOT SHOWN ANY PROBLEMATIC SYMPTOMS AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET DQO, CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA F2586100

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other