BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: PACING 5 FR 110CM 10MM SPACIN

    MDR report key: 4120900 · Received July 28, 2014

    Report

    Report Number
    2242445-2014-00008
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 4, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LDF
    PMA / PMN Number
    K960479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB. DURING INSERTION OF AN AI-07150, THE USER MET WITH INSERTION DIFFICULTY WHEN SETTING THE STYLET INTO THE CATHETER; SEVERAL ATTEMPTS WERE MADE. AS A RESULT, THE STYLET WAS NOT USED. THE USER INSERTED THE CATHETER WITHOUT THE STYLET. THE PROCEDURE WENT ON AS PLANNED. THE RETURNED STYLET WAS BROKEN DUE TO THE REPEATED INSERTION ATTEMPTS. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS, INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY NOTED. THE PATIENT OUTCOME IS ONE CAUSE HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON JULY 09, 2014 CONFIRMED THAT THE PATIENT OUTCOME WAS NO CAUSE HARM TO THE PATIENT. THE STYLET GOT STUCK WHEN INSERTING INTO THE CATHETER. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439792 CATH PKGD: PACING 5 FR 110CM 10MM SPACIN TEMPORARY PACING CATHETER PRODUCTS LDF ARROW INTL., INC. MF3033262

    Patients

    Seq Age Sex Outcome Treatment
    1