BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 3932887 · Received July 14, 2014

    Report

    Report Number
    9616099-2014-00467
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    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

    THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. THE GENDER OF THE PATIENT IS UNKNOWN. COMPLAINT CONCLUSION: DURING USE OF A 5F 55M BRITE TIP SHEATH INTRODUCER, IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT THE DEVICE INTO THE VESSEL, THE DISTAL TIP OF THE DILATOR WAS NOTED TO BE FRAYED. THEREFORE, THE PHYSICIAN STOPPED USING THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER BRITE TIP SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE, ACCESS SITE AND VESSEL CHARACTERISTICS ARE UNKNOWN. THERE WERE NO ANOMALIES NOTED OF THE PRODUCT WHEN IT WAS REMOVED FROM THE PACKAGE NOR DURING ROUTINE PREPARATION OF THE DEVICE PRIOR TO USE IN THE PATIENT. EXCESSIVE FORCE WAS NOT USED TO INSERT THE SHEATH. INVESTIGATION NOTES THAT ¿IT IS UNKNOWN IF A DILATOR WAS USED PRIOR TO INSERTION OF THE SHEATH AND IF DIFFICULTY WAS ENCOUNTERED INSERTING THE PRODUCT INTO THE PATIENT¿S BLOOD VESSEL¿ INITIAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE CANNULA SHEATH INTRODUCER, NOT THE DILATOR, WAS RECEIVED FRAYED/ SPLIT/ TORN DAMAGE. A NON-STERILE SI BRITE TIP F5 55CM CANNULA SHEATH AND A VESSEL DILATOR WERE RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE CSI VESSEL DILATOR WAS RECEIVED WITH NO DAMAGE. HOWEVER, THE CANNULA SHEATH INTRODUCER WAS RECEIVED WITH FRAYED/ SPLIT/ TORN DAMAGE ON TIP OF CANNULA. ALSO, BLOOD RESIDUES OBSERVED ON DISTAL PART OF CANNULA. NO OTHER ANOMALIES WERE FOUND. SEM ANALYSIS WAS PERFORMED ON THE CSI CANNULA SHEATH DISTAL TIP DAMAGED AREA AND SEM RESULTS SHOW THAT THE BRITE TIP SURFACE PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDING AREAS OF THE FRAYED. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE FRAYED CHARACTERISTICS. AS ADDITIONAL INVESTIGATION THE CSI CATHETERS MANUFACTURING PROCESS WAS REVIEWED AND THERE WERE NOT TOOLS, EQUIPMENT OR PRODUCT HANDLING THAT COULD CAUSE FRAYED/SPLIT/TORN OR OTHER TYPE OF DAMAGES ON THE CSI CATHETERS. IN ADDITION, THE CSI CATHETERS ARE INSPECTED DURING MANUFACTURING PROCESS FOR ANY TYPE OF DAMAGE; ALSO, SEVERAL INSPECTIONS ARE PERFORMED THROUGH ALL THE CSI CATHETERS ASSEMBLY PROCESS OPERATIONS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT ¿ENDOVASCULAR VASCULAR ACCESS-VESSEL DILATOR-FRAYED/SPLIT/TORN-IN PATIENT¿ WAS NOT CONFIRMED SINCE NO DAMAGE WAS NOTED OF THE VESSEL DILATOR. HOWEVER, THE CANNULA SHEATH INTRODUCER RECEIVED FOR ANALYSIS WITH THE DILATOR WAS RECEIVED WITH FRAYED/ SPLIT/ TORN DAMAGE ON THE TIP. THE EXACT CAUSE OF THE FRAYED/SPLIT/TORN CONDITION FOUND ON THE CSI CANNULA COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE DEVICE APPEARED AND PREPPED NORMALLY PRIOR TO USE IN THE PATIENT. PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS ARE UNKNOWN BUT MAY BE CONTRIBUTING FACTORS TO THE REPORTED EVENT AS EVIDENCED BY ELONGATIONS NOTED AT THE SURROUNDING AREAS OF THE FRAYED CANNULA DURING SEM ANALYSIS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED COMPLAINT COULD BE RELATED TO THE MANUFACTURING OF THE DEVICE, THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING USE OF A F5 55M BRITE TIP SHEATH INTRODUCER, IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE INSERTED INTO THE VESSEL, BUT THE DISTAL TIP OF THE DILATOR WAS NOTED TO BE FRAYED. THEREFORE, THE PHYSICIAN STOPPED USING THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW BRITE TIP SHEATH. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE CANNULA SHEATH INTRODUCER WAS RECEIVED WITH FRAYED/ SPLIT/ TORN DAMAGE ON TIP OF CANNULA. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PRODUCT APPEARED NORMAL WHEN TAKEN FROM ITS PACKAGING. THERE WAS NO DIFFICULTY FLUSHING OR ASSEMBLING THE DEVICES. THE ACCESS SITE LOCATION AND CHARACTERISTICS ARE UNKNOWN. EXCESSIVE FORCE WAS NOT USED TO INSERT THE SHEATH. IT IS UNKNOWN IF A DILATOR WAS USED PRIOR TO INSERTING THE SHEATH. THE DEVICE APPEARED NORMAL BEFORE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS DIFFICULTY ENCOUNTERED INSERTING THE DEVICE INTO THE VESSEL. THE DEVICE PREPPED NORMALLY. THE DEVICE WAS NOT CLINICALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410977 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 16089478

    Patients

    Seq Age Sex Outcome Treatment
    1