BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYO/WIRE ULTRA-FLEX TEMPORARY PACING WIRE

    MDR report key: 8741742 · Received June 27, 2019

    Report

    Report Number
    2242056-2019-00004
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 27, 2019
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    LDF
    UDI-DI
    20841291100079
    PMA / PMN Number
    K803086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER SENT AN INQUIRY ABOUT APPROPRIATE ATTACHMENT METHOD FOR THE M-21 LOOPED TEMPORARY PACING WIRE. THEY IDENTIFIED A DIFFERENCE IN THE DESCRIPTION OF ATTACHMENT ON THE A&E WEBSITE WHEN COMPARED TO THE IFU CONTENT. CORRECTIVE ACTION TAKEN: IFU WAS UPDATED TO INCLUDE ATTACHMENT INSTRUCTIONS FOR BOTH THE M-21 AND M-22 MODELS OF LOOPED PACING WIRES. ECR 2019-092 REVISED CONTENT WITH UPDATED DIRECTIONS FOR ATTACHMENT. ECR 2019-099 CORRECTED FORMATTING ISSUES PRIOR TO PRINTING AT REVISION 007 OF THE IFU. NEW VERSION OF THE IFU WAS IMMEDIATELY POSTED ON THE A&E WEBSITE. (ECR 2019-093) INVENTORY IN WORK IN PROGRESS AND IN STOCK WAS PLACED ON HOLD TO BE REWORKED WITH REVISED IFUS. FURTHER ANALYSIS: HEALTH HAZARD WAS DETERMINED TO BE REMOTE BASED ON THE FACT THAT THE IFU HAD NO INSTRUCTIONS ON ATTACHMENT TECHNIQUES UNTIL FEBRUARY 2018 (HAS BEEN ON THE MARKET SINCE 1978) AND THE PRODUCT IS USED BY TRAINED SURGEONS WHO ARE WELL VERSED IN ATTACHMENT TECHNIQUES. NO COMPLAINTS ASSOCIATED WITH ATTACHMENT TECHNIQUES HAVE BEEN REPORTED. HOWEVER, IF A SURGEON USED THE TECHNIQUE DESCRIBED IN THE IFU FOR LOOPED WIRES WITH THE M-21 STYLE LOOP, IT IS POSSIBLE THAT THE LOOP WOULD NOT SLIP THROUGH THE SUTURE AND COULD NOT BE REMOVED POST SURGERY. THIS COULD LEAD TO A RETAINED PACING WIRE WHICH IS A WELL-DOCUMENTED POST-OPERATIVE COMPLICATION ASSOCIATED WITH TEMPORARY PACING WIRES. WHILE NOT LIFE THREATENING, IT IS UNDESIRABLE. PRODUCT NOTICE (FIELD ACTION TAKEN): PRODUCT NOTICE SENT TO ALL CUSTOMERS WHO RECEIVED M-21 PACING WIRES WITH REVISION 005 IFUS ADVISING CUSTOMER OF THE CHANGE IN INSTRUCTIONS AND PROVIDING A COPY OF THE UPDATED IFU FOR INCLUSION INTO ANY REMAINING INVENTORY. BEING REPORTED TO THE FDA AS A CLASS II FIELD ACTION.

    Description of Event or Problem · 1

    A CUSTOMER SENT AN INQUIRY ABOUT APPROPRIATE ATTACHMENT METHOD FOR THE M-21 LOOPED TEMPORARY PACING WIRE. THEY IDENTIFIED A DIFFERENCE IN THE DESCRIPTION OF ATTACHMENT ON THE A&E WEBSITE WHEN COMPARED TO THE IFU CONTENT: (WEBSITE DESCRIPTION) "M-21 STYLE, LOOP ELECTRODE: ONE-EIGHTH INCH DIAMETER BARE TEMPORARY CARDIAC PACING WIRE LOOP CAN BE SECURED ONTO THE MYOCARDIUM WITH A NON-TIED CONTINUOUS SUTURE THROUGH THE MYOCARDIUM AND WIRE LOOP. THE SUTURE WILL UNRAVEL DURING REMOVAL." (IFU DESCRIPTION) "ATRIAL LOOP TYPE SURFACE ELECTRODES ARE SECURED BY PLACING A SUTURE AROUND THE ELECTRODE NECK. SUTURE SHOULD BE SNUG, NOT TIGHT. DO NOT PLACE SUTURE THROUGH LOOP, THIS WILL PREVENT REMOVAL OF THE WIRE. LOOP WILL COMPRESS AND PASS THROUGH THE SUTURE WITH GENTLE TRACTION DURING REMOVAL." INVESTIGATION INTO THE INQUIRY DETERMINED THAT DURING AN IFU UPDATE (IFU REVISION 005) IN FEBRUARY 2018, ATTACHMENT INSTRUCTIONS FOR THE M-22 LOOPED ELECTRODE WERE INCLUDED IN THE IFU BUT NOT THE INSTRUCTIONS FOR THE M-21 LOOP. THE UPDATED INSTRUCTIONS DID NOT IDENTIFY THE LOOP TYPE. PRIOR TO THIS CHANGE, THE IFU HAD NO INSTRUCTIONS FOR ATTACHMENT SINCE THE PRODUCT IS STATED TO BE FOR USE BY TRAINED SURGEONS OR SURGICAL PERSONNEL ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535086 MYO/WIRE ULTRA-FLEX TEMPORARY PACING WIRE TEMPORARY PACING WIRE LDF A&E MEDICAL CORPORATION 021-001 20841291100079

    Patients

    Seq Age Sex Outcome Treatment
    1