BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 3132790 · Received May 29, 2013

    Report

    Report Number
    9616099-2013-00323
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY AN AFFILIATE, DURING A PERCUTANEOUS CORONARY INTERVENTION, THE DISTAL PORTION OF A 6F 11CM SI BRITE TIP ENDOVASCULAR VASCULAR SHEATH WAS FRAYED UPON INSERTION. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, IT WAS FINISHED SUCCESSFULLY WITHOUT THE USE OF THE MALFUNCTIONED DEVICE. THE TARGET LESION WAS THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS A DE NOVO, BUT WAS NOT CALCIFIED OR TORTUOUS. THERE WAS 90% STENOSIS. THERE WAS NO INFORMATION AVAILABLE ABOUT THE PUNCTURE SITE. THE SITE COMMENTED ¿THE PHYSICIAN WAS NOT ABLE TO ENTER THE VESSEL WITH THE DEVICE BECAUSE THE DISTAL PORTION OF THE BRITE TIP SHEATH WAS FRAYED.¿ THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. THE CANNULA TIP MOLDING PARAMETERS & (B)(4) RESULTS WERE REVIEWED AND IT WAS FOUND TO PASS. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, THE COMPLAINT COULD NOT BE CONFIRMED. FACTORS THAT COULD CONTRIBUTE TO DEVICE FRAYING UPON INSERTION INCLUDE PUNCTURE SITE CHARACTERISTICS (I.E. SCARRING) AND DEVICE HANDLING (I.E. EXCESSIVE FORCE). WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT. THERE WAS NO INFORMATION PROVIDED TO INDICATE THAT THE COMPLAINT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE SITE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE DISTAL PORTION OF A 6F 11CM SI BRITE TIP ENDOVASCULAR VASCULAR SHEATH WAS FRAYED UPON INSERTION. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, IT WAS FINISHED SUCCESSFULLY WITHOUT THE USE OF THE MALFUNCTIONED DEVICE. THE TARGET LESION WAS THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS A DE NOVO, BUT WAS NOT CALCIFIED OR TORTUOUS. THERE WAS 90% STENOSIS. THERE WAS NO INFORMATION AVAILABLE ABOUT THE PUNCTURE SITE. THE SITE COMMENTED ¿THE PHYSICIAN WAS NOT BE ABLE TO ENTER THE VESSEL WITH THE DEVICE BECAUSE THE DISTAL PORTION OF THE BRITE TIP SHEATH WAS FRAYED.¿ THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236143 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15780005

    Patients

    Seq Age Sex Outcome Treatment
    1