BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACING/PSI KIT: 5 FR 2-L

    MDR report key: 3901705 · Received May 7, 2014

    Report

    Report Number
    1036844-2014-00211
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LDF
    PMA / PMN Number
    K960479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIAC INTENSIVE CARE UNIT (CICU) THE MD INSERTED THE PACING CATHETER EMERGENTLY VIA THE PT'S RIGHT INTERNAL JUGULAR. THE MD INSERTED THE SOCKETED ADAPTER PINS INTO THE GENERATOR EXTENSION CABLE HUB; I.E. REMINGTON CABLE. THE MD ENCOUNTERED DIFFICULTY WHEN ATTACHING THE CATHETERS' SHROUDED CONNECTOR PINS OVER THE SOCKETED ADAPTER PINS. THE PINS JAMMED INSIDE THE SCREW ADAPTER THEREFORE, THE MD WAS UNABLE TO USE THE PACING CATHETER. THE MD REMOVED THE IS-07155-UPM AND INSERTED A COMPETITOR'S PACING CATHETER SUCCESSFULLY. THERE WAS NO REPORTED PT DEATH, INJURY, OR COMPLICATIONS. THERE WAS A DELAY/INTERRUPTION IN THERAPY; HOWEVER, THIS DID NOT CAUSE HARM TO THE PT. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. ADD'L INFO RECEIVED ON (B)(6) 014 FROM THE RN STATED THAT THE TIP DID NOT BREAK OFF AFTER REPEATED INSERTIONS AND COULD INADVERTENTLY JAM THE DISPOSABLE LEAD THEY ARE CURRENTLY USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276699 PACING/PSI KIT: 5 FR 2-L TEMPORARY PACING CATHETER PRODUCTS LDF ARROW INTL., INC. 23F14A0635

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR