BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER SET

    MDR report key: 5221264 · Received November 13, 2015

    Report

    Report Number
    2015691-2015-03055
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQY
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF ¿EDWARDS INTROFLEX DID NOT FIXATE THE TEMPORARY PACEMAKER ELECTRODE" WAS CONFIRMED. THE RETURNED INTROFLEX HEMOSTASIS (NON-ADJUSTABLE) TYPE INTRODUCER IS NOT ADJUSTABLE AND CANNOT BE TIGHTENED AROUND THE RETURNED NON EDWARDS PACING CATHETER. THE TOUHY BORST TYPE CONNECTORS ON THE CONTAMINATION SHIELD WERE NOT ABLE TO BE ADJUSTED FAR ENOUGH TO TIGHTEN AROUND THE CATHETER. NOTE THE INTRODUCER USED BY THE CUSTOMER WAS A I301F6 AND A (B)(4) SIZE LARGER THEN IS RECOMMENDED BY EDWARDS FOR A 5F CATHETER. A LABORATORY SAMPLE INTROFLEX TOUHY BORST (ADJUSTABLE) TYPE I550BF5 INTRODUCER WAS TRIED AND WAS FOUND TO TIGHTEN AROUND THE CATHETER TO FIRMLY HOLD THE CATHETER IN PLACE. ALTHOUGH THE REPORTED EVENT WAS CONFIRMED, THE CUSTOMER IS USING ONE SIZE LARGER INTRODUCER THEN IS RECOMMENDED FOR A 5F CATHETER. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. NO ACTIONS WILL BE TAKEN AT THIS TIME. CORRECTION- THE MODEL NUMBER WAS CORRECTED ONCE RECEIVED IN OUR EDWARDS LABORATORY.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE COMPLETION OF THE PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION RESULTS. LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRODUCER DID NOT FIXATE THE PACEMAKER ELECTRODE LEADING TO DISPLACEMENT. THERE WAS NO CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751597 PERCUTANEOUS SHEATH INTRODUCER SET CATHETER, PERCUTANEOUS DQY EDWARDS LIFESCIENCES PR I301F6

    Patients

    Seq Age Sex Outcome Treatment
    1