BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3173670 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10454
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED CATHETER BODY DAMAGE, OCCURRED TO CATHETER BODY AND OR GUIDE WIRE DURING IMPLANT PROCEDURE. THE COMPLETE DISTAL PORTION OF THE CATHETER AND ITS GUIDEWIRE WERE RETURNED FOR ANALYSIS ALONG WITH THE PROXIMAL PORTION PLUS THE ANCHOR DEPLOYMENT TOOL. AS RECEIVED, THE GUIDEWIRE WAS STILL INSERTED IN THE DISTAL SEGMENT BUT IT WAS NOT PROTRUDING FROM ANY OF THE DISPENSING HOLES. HOWEVER, THE GUIDEWIRE WAS NOT FULLY ADVANCED INSIDE THE CATHETER BUT INSTEAD ITS TIP WAS LOCATED BETWEEN THE MEDIAL AND MOST DISTAL DISPENSING HOLES. EVENT INFORMATION INDICATES THE ISSUE OCCURRED WHILE ATTEMPTING TO IMPLANT THE CATHETER RATHER THAN THE GUIDEWIRE PROTRUDING FROM THE DISPENSING HOLES WHEN THE CATHETER WAS REMOVED FROM ITS PACKAGING. THE GUIDEWIRE WAS REMOVED FROM THE CATHETER FOR DECONTAMINATION PURPOSES. AFTER THIS STEP, THE GUIDEWIRE WAS RE-INSERTED ALL THE WAY INTO THE CATHETER. IT WENT ALL THE WAY TO THE END OF THE CATHETER AND DID NOT PROTRUDE THROUGH ANY DISPENSING HOLES. A SLIGHT BEND IN THE CATHETER WAS NOTED IN THE AREA OF THE MOST DISTAL SET OF DISPENSING HOLES. THIS IS POSSIBLY RELATED TO WHERE THE GUIDEWIRE WAS PROTRUDING THROUGH THE DISPENSING HOLES.-ALSO, OF NOTE WAS A SIGNIFICANT AREA OF BENDING OF THE GUIDEWIRE MEASURED 14 TO 15.5 CM FROM ITS VERY TIP. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8780, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE DAY OF THE REPORT WHEN THE HCP TRIED REPOSITIONING THE CATHETER TIP FOR A NEW IMPLANT TWICE, THE GUIDE WIRE POKED OUT OF A HOLE AT THE TIP OF THE CATHETER. THE HCP HAD PULLED THE CATHETER OUT BECAUSE IT WAS GOING DOWN AND THE STYLET POPPED OUT THE BOTTOM OF THE CATHETER LIKE IN A SIDE PORT. A NEW CATHETER WAS UTILIZED WITH NO ISSUES. THE PUMP WAS USED TO DELIVER SALINE. IT WAS LATER REPORTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273041 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1