BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: WEDGE 6 FR 11 0CM

    MDR report key: 2241176 · Received August 17, 2011

    Report

    Report Number
    2242445-2011-00107
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYG
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    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 THAT THE EVENT OCCURRED WHILE IN THE ANGIO DEPARTMENT WITH NO PT INVOLVEMENT. DURING PRODUCT PREP, THE STAFF FOUND THAT THE BALLOON DID NOT INFLATE WHILE PREPARING FOR THE PROCEDURE. AS A RESULT, THE KIT WAS NOT USED. A NEW KIT WAS OPENED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT NOTED. NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME WAS NO HARMFUL OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: WEDGE 6 FR 11 0CM BALLOON WEDGE PRESSURE CATHETER PRODUCTS DYG ARROW INTERNATIONAL INC MF0073866

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK