BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH-LAB SHEATH INTRO SET:

    MDR report key: 3223860 · Received July 10, 2013

    Report

    Report Number
    9680794-2013-00038
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTROL NO: (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN TREATMENT / MEDICAL PROCEDURE "CLAUDICATION" (FOR PERIPHERAL ARTERY DISEASE) THE CATHETER WAS INSERTED OVER THE SPRING WIRE GUIDE (SWG) AND THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH. THE MD FOUND THAT THE CATHETER COULD NOT BE REMOVED FROM THE SAF SHEATH AND AS A RESULT, THE SHEATH AND CATHETER WERE REMOVED AS ONE UNIT. ACCORDING TO THE CUSTOMER'S REPORT, "THE LAST PART OF THE SUPER ARROW-FLEX SHEATH, THE TIP OF THE WIRE GETS CLENCHED ON THE INTRODUCED BALLOON, THUS MAKING IT IMPOSSIBLE TO HAVE THE CATHETER REMOVED BY ITSELF. THE PT SUFFERS HEAVY BLEEDING". THIS EVENT HAS OCCURRED SEVERAL TIMES. THERE WAS NO REPORTED DEATH; HOWEVER, THERE WAS REPORTED PT INJURY I.E. PT SUFFERS HEAVY BLEEDING. THE PT OUTCOME IS LISTED AS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315081 CATH-LAB SHEATH INTRO SET: INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other