BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 2221369 · Received August 24, 2011

    Report

    Report Number
    9616099-2011-00663
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT RADIAL ARTERY HAD MODERATE VESSEL TORTUOSITY. WHEN THE PHYSICIAN ADVANCED THE CATHETER, HE FELT FRICTION AS THE VESSEL WAS MODERATELY TORTUOUS. EXCESSIVE TORQUING WAS REQUIRED, AS THE PHYSICIAN FELT FRICTION DURING THE ADVANCEMENT PROCESS. THE PRODUCT WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED BACK FOR INVESTIGATION. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREP. IT IS UNKNOWN IF THE AREA OF SEPARATION WAS WHERE THE DEVICE HAD KINKED, AS NO KINK WAS NOTICED WHEN THE DEVICE WAS PREPPED. THE CATHETER WAS ADVANCED VIA THE SHEATH. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION VIA THE LEFT RADIAL APPROACH, WHEN ADVANCING THE VISTABRITE 6F .070 JR 3.5 100CM GUIDING CATHETER WITH THE GUIDEWIRE THERE WAS RESISTANCE DUE TO MODERATE VESSEL TORTUOSITY REQUIRING EXCESSIVE TORQUING. DURING THE WITHDRAWAL PROCESS THERE WAS SUDDEN VESSEL SPASM RESULTING IN SEPARATION OF THE GUIDING CATHETER 50-60CM FROM THE DISTAL END. THE BROKEN PART REMAINED IN THE LEFT BRACHIAL ARTERY. MEDICATION WAS ADMINISTERED TO RELIEVE THE VESSEL SPASM WITH CONVERSION TO AN OPEN PROCEDURE TO REMOVE THE BROKEN GUIDING CATHETER. IT WAS REPORTED THAT PATIENT WAS IN STABLE CONDITION. THE PLANNED INTERVENTIONAL PROCEDURE WAS NOT COMPLETED. PRIOR TO THE EVENT AFTER RIGHT RADIAL ACCESS WAS OBTAINED A 6F JR4.0 GUIDING CATHETER KINKED WHEN IT WAS ADVANCED DUE TO SEVERE VESSEL TORTUOSITY. THE ACCESS SITE WAS THEN CHANGED TO THE LEFT RADIAL. THE 6F VISTABRITE JR3.5 CATHETER IS NOT AVAILABLE FOR ANALYSIS; IT WAS DISCARDED AT THE HOSPITAL. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15346402 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. TRACKING DIFFICULTY AND VASOSPASM, OR CONTRACTION OF SMOOTH MUSCLE FIBERS IN THE WALL OF A VESSEL AS A RESULT OF DIRECT PHYSICAL IRRITATION OF THE ENDOTHELIUM IS A KNOWN POTENTIAL EVENT ASSOCIATED WITH ENDOVASCULAR PROCEDURES ESPECIALLY WITH RADIAL APPROACH. FRICTION BETWEEN THE INNER LUMEN OF THE ARTERY AND THE SHEATH OR CATHETER CAN CAUSE PHYSICAL IRRITATION AND SPASM. THIS CAN MAKE SHEATH AND CATHETER REMOVAL DIFFICULT. OTHER CAUSES OF SPASM INCLUDE TORTUOUS ARTERY, DISEASED VESSEL AND SMALL VESSEL DIAMETER. ALTHOUGH WITHOUT THE RETURN OF THE DEVICE FOR EVALUATION NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE REPORTED INFORMATION IT APPEARS THAT VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT CORONARY ANGIOGRAPHY (CAG) REVEALED THAT MIDDLE-TO-DISTAL RIGHT CORONARY ARTERY (RCA) HAD 70%-80% STENOSIS. THE LESION WAS MODERATELY CALCIFIED. DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING PROCEDURE, THE PHYSICIAN SELECTED THE RIGHT RADIAL ARTERY AS THE PUNCTURE SITE AND ADVANCED A 6F JR4.0 GUIDING CATHETER. THE GUIDING CATHETER WAS KINKED DUE TO THE SEVERE TORTUOSITY OF THE RIGHT RADIAL ARTERY. THEN, THE PHYSICIAN CHANGED TO SELECT THE LEFT RADIAL ARTERY AS THE PUNCTURE SITE. HOWEVER, AFTER THE PHYSICIAN ADVANCED THE 6F JR3.5 GUIDING CATHETER AND THE GUIDEWIRE FOR A LITTLE DISTANCE, THE LEFT RADIAL ARTERY SUDDENLY HAD VESSEL SPASM AND CAUSED THE GUIDING CATHETER TO BREAK/SEPARATE. THE VESSEL SPAM OCCURRED DURING THE DEVICE WITHDRAWAL PROCESS. THE DEVICE SEPARATE 50-60CM FROM THE DISTAL END. THE BROKEN PART REMAINED IN THE LEFT BRACHIAL ARTERY. THEN, THE PATIENT WAS TREATED WITH MEDICATION TO RELIEVE THE VESSEL SPASM AND THE PHYSICIAN CONVERTED IT TO AN OPEN PROCEDURE TO TAKE OUT THE BROKEN GUIDING CATHETER. SO FAR, THE PATIENT WAS IN STABLE CONDITION AND WAS NOT TREATED WITH PCI STENTING ANY FURTHER. THE PATIENT HAD BEEN HOSPITALIZED FOR A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15346402

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R