BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 1637159 · Received March 19, 2010

    Report

    Report Number
    1036844-2010-00075
    Event Type
    Death
    Date Received
    March 19, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 19, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE SPRING WIRE GUIDE (SWG) UNRAVELED AND BECAME STUCK INSIDE PATIENT (PT). AS A RESULT, THE USER HAD TO TAKE EXTRA STEPS TO REMOVE THE SWG FROM THE PT. PER AN E-MAIL ON 03/04/2010, THE CATHETER WAS INSERTED BY THE MD IN THE EMERGENCY ROOM. IT WAS REPORTED THAT PT IS NOW DECEASED, BUT CUSTOMER STATED THE CAUSE OF DEATH WAS NOT DUE TO THIS SITUATION. THE CORONER REPORTS SEPSIS AND RESPIRATORY FAILURE AS THE CAUSE OF DEATH. THERE IS A DISCREPANCY WHETHER THERE WAS A DOUBLE LUMEN OR A TRIPLE LUMEN PLACED IN THIS PT. THE HOSPITAL DID NOT KEEP THE PACKAGING, THEREFORE, THE PRODUCT NUMBER AND LOT NUMBER ARE BOTH UNK AT THIS TIME. HOWEVER, THE HOSPITAL WILL AT LEAST PROVIDE THE SALES REPRESENTATIVE WITH THE LOT NUMBER THAT IS CURRENTLY IN THE HOSPITAL. THE CUSTOMER STATED THAT AN X-RAY SUGGESTED THAT THE SWG HAD LOOPED AROUND AT THE END. HOWEVER, WHEN AN ULTRASOUND WAS PERFORMED, IT DID NOT SHOW THIS. IT DID SHOW THAT THE SWG WAS SITUATED IN TISSUE. THE ULTRASOUND ALSO SHOWED THAT THE VESSEL WAS OKAY. THE CATHETER WAS REMOVED ON 02/16/2010 BY A SURGEON IN THE INTENSIVE CARE UNIT (ICU). THE INSERTING PHYSICIAN DESCRIBED THE SITUATION, THE STEPS HE TOOK AND WHEN HE FIRST NOTICED THAT HE ENCOUNTERED A PROBLEM: INSERTED WIRE THROUGH THE ARROW RAULERSON SYRINGE (ARS) AND NEEDLE, AND NOTICED RESISTANCE. AFTER REMOVING SYRINGE/NEEDLE FROM SWG, THREADED THE DILATOR OVER SWG AND INTO PT. THIS DID NOT HAVE THE SAME FEELING IN TERMS OF SOUND/FEELING THAT IT NORMALLY MAKES. AFTER REMOVING THE DILATOR, HE STATED THAT HE ATTEMPTED TO INSERT THE CENTRAL VENOUS CATHETER (CVC), BUT HAD DIFFICULTY, SO REMOVED THE CVC. HE THEN TRIED TO REMOVE THE SWG, BUT HAD DIFFICULTY AND NOTICED THAT THE SWG HAD "DECOILED." HE COULD SEE THIS AT THE ENTRY SITE IN THE PATIENT. AT THIS POINT, HE WAS NERVOUS TO ATTEMPT TO REMOVE THE SWG, SO THE WIRE WAS SECURED SO THAT IT WOULDN'T FLY AROUND AND PT WAS MOVED TO THE ICU. IN THE ICU, A SURGEON DID REMOVE THE SWG SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death