BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS

    MDR report key: 1057158 · Received June 5, 2008

    Report

    Report Number
    6000002-2008-07499
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Date of Event
    March 28, 2008
    Report Date
    May 19, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO ADDITIONAL LOT NUMBERS PROVIDED WHEN DEVICE WAS RETURNED: EXPIRATION DATE:05/01/2009; MANUFACTURE: 11/01/2007; LOT NUMBER 247DC951; EXPIRATION DATE:10/01/2008; MANUFACTURE DATE: 04/25/2007. ALL THREE DEVICES WERE RETURNED AND EVALUATED. ONE DEVICE WAS MISSING BALLOON LATEX. UNIT# 1-CUSTOMER REPORT WAS CONFIRMED. RETURNED PAPERWORK INDICATED THREE DIFFERENT LOT NUMBERS (58439125, 247DC951 AND 58466939). BALLOON RUPTURED ALMOST ALL THE WAY AROUND THE CIRCUMFERENCE. NO INTRODUCER RETURNED. UNIT# 2 - CUSTOMER REPORT WAS CONFIRMED. RETURNED PAPERWORK INDICATED THREE DIFFERENT LOT NUMBERS (58439125, 247DC951 AND 58466939). BALLOON RUPTURED ALMOST ALL THE WAY AROUND THE CIRCUMFERENCE. RUPTURED PORTION OF LATEX IS INVERTED OVER THE DISTAL TIP. NO INTRODUCER RETURNED. UNIT#3 - CUSTOMER REPORT WAS CONFIRMED. RETURNED PAPERWORK INDICATED THREE DIFFERENT LOT NUMBERS (58439125, 247DC951, 247DC951 AND 58466939). BALLOON LATEX HAS DETACHED BETWEEN THE PROXIMAL AND DISTAL BONDS. DETACHED LATEX WAS NOT RETURNED. RESIDUAL LATEX IS PRESENT ON BOTH BOND SITES. NO INTRODUCER RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, ALL THREE BALLOONS BURST DURING INSERTION THROUGH THE INTRODUCER SHEATH (ARROW). NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58466939

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other