BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SE T:

    MDR report key: 1994253 · Received January 14, 2011

    Report

    Report Number
    9680794-2011-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING USED ON A MALE PT WITH TORTUOUS ANATOMY. THE SHEATH WAS PLACED IN THE PT'S LEFT FEMORAL AND THEY HAD DIFFICULTY PASSING EQUIPMENT THROUGH THE SHEATH. AT WHICH TIME, THEY DECIDED TO EXCHANGE THE SHEATH AND A SPRING WIRE GUIDE (SWG) WAS PASSED. UPON REMOVAL OF THE SHEATH, THEY FOUND IT HAD STARTED TO UNRAVEL. THE SHEATH WAS REMOVED INTACT FROM THE PT, AND ANOTHER SHEATH WAS PLACED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT WAS FINE. ADD'L INFO RECEIVED ON 01/04/2011 FROM THE HOSPITAL STATED THAT THEY ATTEMPTED TO PASS THREE DIFFERENT CATHETERS THROUGH THE SHEATH. THE FIRST ONE WAS AN EB3 NANOCROSS, THE SECOND WAS A CSI PREDATOR CATHETER AND THIRD WAS A SPECTRENETICS LASER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH-LAB SHEATH INTRO SE T: INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC CF7085279

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR CSI PREDATOR CATHETER| SPECTRENETICS LASER CATHETER| EB3 NANOCROSS CATHETER