BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: WEDGE 5 FR 11 0CM

    MDR report key: 2772194 · Received October 2, 2012

    Report

    Report Number
    2242445-2012-00129
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYG
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD PRETESTED THE WEDGE PRESSURE CATHETER SUCCESSFULLY. THE MD INSERTED THE CATHETER VIA THE PT'S RIGHT FEMORAL ARTERY. LESS THAN ONE MINUTE LATER WHEN THE MD TRIED TO INFLATE THE WEDGE PRESSURE BALLOON IT WOULD NOT INFLATE AND AS A RESULT, THE CATHETER WAS REMOVED AND ANOTHER WEDGE PRESSURE CATHETER WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED PT DEATH, INJURY OR COMPLICATIONS. THERE WAS A DELAY/INTERRUPTION IN THERAPY FOR THE TIME FRAME REQUIRED TO RETRIEVE, PRETEST AND INSERT THE SECOND CATHETER. THE PT OUTCOME IS UNK. ADD'L INFO RECEIVED FROM THE MGR CLINICAL SUPPORT, TRAINING AND DEVELOPMENT, TELEFLEX (B)(4) ON (B)(6) 2012 STATED THE PT HAD THE PROCEDURE DONE SUCCESSFULLY AND NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: WEDGE 5 FR 11 0CM BALLOON WEDGE PRESSURE CATHETER PRODUCTS DYG ARROW INTL., INC. MF2048589

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR