BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: THERMISTOR 6 110CM

    MDR report key: 2934926 · Received January 25, 2013

    Report

    Report Number
    2242445-2013-00014
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DYG
    PMA / PMN Number
    K833572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CATH LAB PRIOR TO INSERTION. DURING PRETEST WHEN THE USER INFLATED THE BALLOON USING THE SYRINGE IN THE KIT, THE BALLOON RUPTURED. AS A RESULT, THE KIT WAS NOT USED. A NEW KIT WAS OPENED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS, OR INJURY. THERE WAS A DELAY NOTED WITH NO HARM TO THE PT. THE PT OUTCOME IS GOOD. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 STATED THE USER DOES NOT KNOW THE EXACT INFLATION VOLUME USED, BUT THEY DID USE THE SYRINGE FROM THE KIT TO INFLATE THE BALLOON. AN UPDATE OF (B)(4) 2013 CLARIFIED THAT THIS EVENT OCCURRED AFTER INSERTION, NOT PRIOR TO INSERTION AS ORIGINALLY STATED. REF MDR #2242445-2013-00015 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36196 CATH PKGD: THERMISTOR 6 110CM BALLOON THERMODILUTION CATHETER PRODUCTS DYG ARROW INTERNATIONAL MF2080315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK