BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: WEDGE 4 FR 60 CM

    MDR report key: 1943958 · Received December 3, 2010

    Report

    Report Number
    2242445-2010-00074
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYG
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE PEDIATRIC CARDIAC LAB THE AI-07121 WAS PRETESTED WITHOUT DIFFICULTIES. THE MD INSERTED THE CATHETER INTO THE PT'S FEMORAL ARTERY. THE WEDGE PRESSURE CATHETER RUPTURED DURING USE AND AS A RESULT, WAS REMOVED FROM THE PT. THE MD INSERTED ANOTHER AI-07121 WITHOUT INCIDENT. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED DUE TO THIS INCIDENT. THE DELAY / INTERRUPTION WAS UNTIL THE SECOND CATHETER WAS PRETESTED AND INSERTED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: WEDGE 4 FR 60 CM BALLOON WEDGE PRESSURE CATHETER PRODUCTS DYG ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN