BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 3222443 · Received July 12, 2013

    Report

    Report Number
    9616099-2013-00436
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM A SALES REP INDICATED THAT THE HUB OF A 6FR VISTA BRITE GUIDING CATHETER CRACKED AFTER THE WIRE WAS REMOVED AND LEAKED DURING A PROCEDURE. THE DEVICE WAS REMOVED AND ANOTHER WAS USED WITH NO FURTHER PROBLEMS. THE GUIDE CATHETER WAS PUT INTO THE PATIENT USING A NON-CORDIS SHEATH AND OVER AN UNKNOWN BRAND 0.035 WIRE. FOLLOWING THE REMOVAL OF THE WIRE, THE CATHETER BEGAN TO LEAK THROUGH A CRACK AT THE ¿YELLOW HUB¿, ACCORDING TO THE TECH. IT WAS STATED THAT THE LEAK OCCURRED AT THE BEGINNING OF THE PROCEDURE WHEN THE DEVICE WAS INSERTED INTO THE PATIENT. THE WIRE WAS NOT EXCHANGED FOR ANOTHER WIRE. IT IS UNKNOWN WHAT THE INTENDED PROCEDURE/TARGET LESION WAS. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR ANALYSIS. FAL: ONE NON STERILE UNIT OF VISTA BRITE 6F .070 WAS RECEIVED COILED IN PLASTIC BAG, THE LUER HUB OF THE CATHETER WAS FOUND CRACKED. NO OTHER ISSUES WERE FOUND. A LAB SAMPLE SYRINGE WITH WATER WAS ATTACHED TO THE CATHETER HUB AND IT WAS FLUSHED; LEAKAGE WAS NOTED ON THE HUB AT CRACKED AREA. THE LUER HUB OF THE CATHETER WAS INSPECTED UNDER MICROSCOPE AND THE CRACKED CONDITION WAS CONFIRMED. SEM ANALYSIS WAS PERFORMED ON THE CRACKED AREA WITH THE FOLLOWING RESULTS: PER SEM RESULTS, THE RECEIVED HUB MATERIAL PRESENTED EVIDENCE OF SEVERE ABRASION ON THE HUB THREAD; IT IS NOTEWORTHY TO MENTION THAT THE ABRASION MARKS ARE ALSO PRESENT ON THE SURROUNDINGS OF THE CRACK PATH. THE INTERNAL WALL FOR THE HUB MATERIAL EXHIBITED SOME AREAS WHICH LOOKED BRITTLE IN APPEARANCE; MOREOVER, NO EVIDENCE OF DEFORMATION, CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. NO EVIDENCE OF DUCTILITY WAS FOUND ON HUB SURFACE. ACCORDING TO THE OBSERVED CONDITIONS, THE OBSERVED CRACK OCCURRED IN A BRITTLE MANNER POTENTIALLY CAUSED BY DEVICE HANDLING. DSC & TGA ANALYSES WERE PERFORMED TO THE CRACKED AREA WITH THE FOLLOWING RESULTS: THE COMPLAINT SAMPLE SUBMITTED FOR ANALYSIS EXHIBITED BRITTLENESS; THIS CHANGES THE MECHANICAL PROPERTIES OF THE MATERIAL CAUSING A BRITTLE FRACTURE AS THOSE COMMONLY FOUND ON CERAMICS. DSC TEST DETERMINED THE FRACTURE OBSERVED IN THE HUB WAS BRITTLE BASED ON THE GLASS TRANSITION TEMPERATURE; HUB UNDERGOES A BRITTLE FRACTURE SINCE GLASS TRANSITION TEMPERATURE CALCULATED FOR THE SAMPLES WAS APPROXIMATELY 140 °C. THERMAL STABILITY OF THE SAMPLES WAS EVALUATED BY TGA; RESULTS SHOWED NO SIGNIFICANT DIFFERENCE IN DECOMPOSITION RATES BETWEEN COMPLAINT AND CONTROL SAMPLES; MEANING NO DIFFERENCE IN MATERIAL COMPOSITION OR RATIO. THE REPORTED CUSTOMER COMPLAINT OF LUER HUB CRACKED WAS CONFIRMED THROUGH FAILURE ANALYSIS. THE ROOT CAUSE FOR THIS EVENT HAS NOT CONCLUSIVELY BEEN DETERMINED; HOWEVER ACCORDING TO THE ANALYSIS RESULTS A BRITTLE CONDITION FOUND ON THE HUB MAY HAVE OCCURRED AS A RESULT OF THE MANUFACTURING PROCESS. AN INVESTIGATION WAS PREVIOUSLY OPENED TO ADDRESS THIS ISSUE AND THIS LOT OF PRODUCT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE 6F VISTA BRITE TIP GUIDING CATHETER, A LEAK OCCURRED AROUND THE CRACK OF THE ¿YELLOW HUB¿ AFTER THE WIRE WAS REMOVED. THE DEVICE WAS REMOVED AND ANOTHER WAS USED WITH NO FURTHER PROBLEMS. THERE WAS NO REPORTED PATIENT INJURY. THE GUIDE CATHETER WAS PUT INTO THE PATIENT USING A NON-CORDIS SHEATH AND OVER AN UNKNOWN BRAND 0.035 WIRE. FOLLOWING THE REMOVAL OF THE WIRE, THE CATHETER BEGAN TO LEAK THROUGH A CRACK AT THE ¿YELLOW HUB¿, ACCORDING TO THE TECH. IT WAS STATED THAT THE LEAK OCCURRED AT THE BEGINNING OF THE PROCEDURE WHEN THE DEVICE WAS INSERTED INTO THE PATIENT. THE WIRE WAS NOT EXCHANGED FOR ANOTHER WIRE. IT IS UNKNOWN WHAT THE INTENDED PROCEDURE/TARGET LESION WAS. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322766 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15854242

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO SHEATH.035 WIRE (UNKNOWN BRAND)