BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: WEDGE 6 FR 11 0CM

    MDR report key: 2002517 · Received January 28, 2011

    Report

    Report Number
    2242445-2011-00010
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 27, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYG
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    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 ON (B)(6) 2010, THE PATIENT ARRIVED IN THE CATH LAB. THE TIME WAS NEARING MIDNIGHT AND THE AI-07126 WAS INSERTED (B)(6) 2010. THE INTENSIVE CARE UNIT MEMBER "HAD ISSUES WITH DAMPENED WAVE FORM." THE WEDGE PRESSURE CATHETER WAS PULLED IN THE MORNING OF (B)(6) 2010. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT THE CATHETER WAS "CHECKED WITH FLUID AND AT THAT TIME A HOLE WAS NOTICED." THE PATIENT DID NOT REQUIRE ANOTHER WEDGE PRESSURE CATHETER. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT OUTCOME IS FINE, NO ADVERSE EFFECTS. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE ON (B)(6) 2011, STATED THAT THE INSERTION SITE IS THE RIGHT HEART. THE DAMPENING BEGAN 24 HOURS AFTER THE AI-07126 WAS INSERTED. THE MD WAS NOTIFIED AND TOLD THE STAFF "NOT TO WEDGE."

    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 INTL., INC. MF0105262

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN