BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPLIT XK LONG-TRM HEMODIALYSIS CATHETER 16F STANDARD

    MDR report key: 4798520 · Received May 22, 2015

    Report

    Report Number
    3006260740-2015-00229
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    December 1, 2014
    Report Date
    May 15, 2015
    Manufacturer
    BARD EYNOSA S.A DE C.V
    Product Code
    MSD
    PMA / PMN Number
    K033294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REXL1018 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2015 PER MEDWATCH: REPORTEDLY A PORTION OF A GUIDEWIRE BROKE OFF DURING THE PLACEMENT OF AN INTERNAL JUGULAR HEMODIALYSIS CATHETER. THE DEVICE FRAGMENT WAS FOUND TO BE WITHIN THE SVC AND RIGHT ATRIUM. THE GUIDEWIRE WAS NOT NOTED TO HAVE BROKEN DURING THE INITIAL PROCEDURE. THE DEVICE FRAGMENT WAS FOUND ON FLUOROSCOPY ON (B)(6) 2014, WHEN ANOTHER DIALYSIS CATHETER WAS PLACED AS THE ONE PLACED ON (B)(6) 2014 WAS NOT FUNCTIONING WELL. AFTER MULTIPLE CONSULTANTS WITH AN INTERVENTIONAL RADIOLOGIST AND A CARDIOTHORACIC SURGEON THE PATIENT WAS TRANSFERRED ON (B)(6) 2014 TO A TERTIARY MEDICAL CENTER FOR ENDOVASCULAR REMOVAL OF THE DEVICE FRAGMENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED WITHOUT FURTHER COMPLICATIONS ON (B)(6) 2014. THE PROCEDURE PERFORMED ON (B)(6) 2014 WAS DIFFICULT, THE SURGEON TRIED TO INSERT IN RIGHT JUGULAR AND WAS UNABLE SO SWITCHED TO LEFT JUGULAR. IT WAS THEN NOTED THAT THE GUIDEWIRE DID "KINK" AND WAS RETURNED "BENT". NEITHER THE PHYSICIAN OR THE STAFF NOTED THAT THE END OF THE CATHETER HAD BROKEN OFF OR SHEARED OFF. BUT X-RAY THE RETAINED PART OF THE CATHETER MAY BE 8 TO 16CM IN LENGTH. PER RADIOLOGIST AN ACCURATE MEASUREMENT IS NOT AVAILABLE PER X-RAY. DIAGNOSIS FOR USE RENAL FAILURE - HEMODIALYSIS. SINCE THE BROKEN GUIDEWIRE WAS NOT NOTED DURING THE PROCEDURE THE PRODUCT WAS NOT RETAINED, THEREFORE UNSURE WHICH OF THE TWO GUIDEWIRES USED ABOVE DURING THE PROCEDURE BROKE OF WERE ACCIDENTALLY SHEARD OFF. (B)(6). MW REF #5040084.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337369 HEMOSPLIT XK LONG-TRM HEMODIALYSIS CATHETER 16F STANDARD MSD BARD EYNOSA S.A DE C.V NA REXL1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NI ON MEDWATCH