BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 3973472 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01761
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WITH ATTACHED MONOJECT 1.3 CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION WITH THE ORIGINAL OPENED PACKAGING BOX. NO INTRODUCER WAS RETURNED. VISUAL EXAMINATION FOUND THAT THE CATHETER BODY WAS COMPLETELY BROKEN OFF ALONG THE PROXIMAL ELECTRODE BONDING SITE. THE CROSS SURFACE OF THE BROKEN CATHETER BODY APPEARED UNEVEN AND ROUGH. THE DISTAL AND PROXIMAL LEADWIRES WERE COMPLETELY BROKEN OFF AT APPROXIMATELY 5 CM AND 2.5 CM PROXIMAL FROM THE CATHETER TIP, RESPECTIVELY. IT WAS NOTED THAT THE PROXIMAL LEADWIRE DID NOT HAVE INSULATION AND THE CROSS SURFACE OF THE BROKEN LEADWIRES APPEARED TAPERED. THERE WAS NO INDICATION OF STRETCHING TO THE CATHETER BODY. CONTINUITY TESTING CONFIRMED NO OPEN, INTERMITTENT, OR SHORT CONDITIONS FROM THE DISTAL AND PROXIMAL CIRCUITS IN THE BROKEN TIP, BETWEEN THE BROKEN SECTIONS AND RELATED ELECTRODES. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE COMPLAINT OF INSERTION DIFFICULTY WAS NOT CONFIRMED DURING THE EVALUATION; HOWEVER, THE COMPLAINT OF BROKEN TIP AT THE ELECTRODE WAS CONFIRMED. IT IS NOT KNOWN IF SOME CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS DIFFICULT TO INSERT THE CATHETER DURING USE. THE CATHETER WAS REMOVED FROM THE PATIENT AND WHEN THE DOCTOR TOUCHED THE TIP OF THE CATHETER, IT GOT BROKEN OFF AT THE ELECTRODE AT 2-3CM FROM THE TIP." THERE SEEMED TO BE NO ABNORMALITIES NOTED ON THE CATHETER BEFORE INSERTION. THERE WERE NO MISSING PARTS REMAINING IN THE PATIENT BODY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451079 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5 59713519

    Patients

    Seq Age Sex Outcome Treatment
    1