BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1900565 · Received October 29, 2010

    Report

    Report Number
    1219856-2010-00762
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER RECEIVING A FIELD SERVICE ALERT (FSA), THE CATH LAB MANAGER WAS INFORMED BY THE INTERVENTIONAL CARDIOLOGIST THAT HE HAD DIFFICULTIES DESCRIBED IN THE FSA; THE MD STATED "HAPPENED TO ME SUNDAY NIGHT, PT IN SHOCK." ON (B)(6) 2010, THE SALES REP VISITED THE CUSTOMER. THE PHYSICIAN'S ASSISTANT STATED THAT THE INTRA-AORTIC BALLOON (IAB) "GOT STUCK IN THE SHEATH, THEY OPENED ANOTHER IAB AND SUCCESSFULLY INSERTED THE SECOND ONE." THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE DELAY IN IAB THERAPY WAS LISTED AS "UNTIL ANOTHER IAB COULD BE INSERTED." THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS "OK." ADDITIONAL INFO RECEIVED FROM THE SALES REP ON (B)(6) 2010, STATED THAT ON (B)(6) 2010, SHE IN-SERVICED THE STAFF AND PHYSICIANS IN THE CATH LAB AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK