BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAGNOSTIC CARDIOLOGY CATHETER- 6F

    MDR report key: 3693587 · Received March 21, 2014

    Report

    Report Number
    9616099-2014-00205
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    March 14, 2012
    Report Date
    February 27, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT, FROM THE FEMORAL ARTERY, A 5-FR KUMPE CATHETER (COOK MEDICAL INC) WAS ADVANCED OVER A 0.035¿ WIRE INTO THE RIGHT SUBCLAVIAN ARTERY, AND A SELECTIVE RIGHT UPPER EXTREMITY ANGIOGRAM WITH DISTAL RUN-OFF WAS PERFORMED, WHICH DEMONSTRATED NO VASCULAR COMPLICATION. FINALLY, SELECTIVE CORONARY ANGIOGRAPHY WAS PERFORMED USING 6-FR JL4 AND JR4 CATHETERS VIA THE RIGHT FEMORAL ARTERY WHICH SHOWED MULTIVESSEL CORONARY DISEASE INCLUDING THE LEFT MAIN. HE WAS THEN REFERRED FOR CORONARY BYPASS SURGERY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    UPDATED CC AN ARTICLE BY KHOUBYARI, R., ARSANJANI, R., HABIBZADEH, M. R., ECHEVERRI, J., & MOVAHED, M. R. (2012). ¿SUCCESSFUL REMOVAL OF AN ENTRAPPED AND KINKED CATHETER DURING RIGHT TRANSRADIAL CARDIAC CATHETERIZATION BY SNARING AND UNWINDING THE CATHETER VIA FEMORAL ACCES¿NOTED THAT WHILE ENGAGING THE RIGHT CORONARY ARTERY, A 5FR JR5 CORDIS CATHETER BECAME KINKED AND THE PHYSICIAN WAS UNABLE TO ADVANCE, WITHDRAW OR MANIPULATE THE CATHETER. THE CATHETER WAS SNARED VIA FEMORAL ACCESS, AND A SELECTIVE RIGHT UPPER EXTREMITY ANGIOGRAM WITH DISTAL RUN-OFF WAS PERFORMED, WHICH DEMONSTRATED NO VASCULAR COMPLICATION. AFTER PLACEMENT OF A 5F SHEATH IN THE RIGHT RADIAL ARTERY, A 5F JR5 CATHETER WAS EASILY ADVANCED INTO THE AORTIC ROOT. THE PHYSICIAN THEN EXPERIENCED GREAT DIFFICULTY ENGAGING THE RIGHT CORONARY ARTERY. DURING REPEATED ATTEMPTS TO ENGAGE THE ARTERY , THERE WAS A SUDDEN LOSS OF AORTIC PRESSURE TRACING AND THE PHYSICIAN WAS UNABLE TO ASPIRATE BLOOD FROM THE CATHETER LUMEN. FLUOROSCOPY REVEALED A 360 DEGREE KINKED LOOP IN THE CATHETER. ATTEMPTS TO UNKINK THE CATHETER USING A 0.035 J WIRE WAS UNSUCCESSFUL. THE PHYSICIAN WAS ALSO UNABLE TO ADVANCE, WITHDRAW OR MANIPULATE THE CATHETER DESPITE ADMINISTRATION OF MULTIPLE MEDICATIONS TO PREVENT VESSEL SPASM. A 7F CORDIS SHEATH WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY. A 7F SNARE CATHETER WAS ADVANCED INTO THE AORTIC ARCH AND WAS USED TO CAPTURE THE DISTAL END OF THE JR5 CATHETER. THE JR5 CATHETER WAS THEN REMOVED FROM THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED ¿CANNULATION DIFFICULTY¿, ¿KINK/BENT IN PATIENT¿ AND ¿WITHDRAWAL DIFFICULTY FROM VESSEL¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE . CANNULATION DIFFICULTY OCCURRING DURING THE CLINICAL USE OF THE DEVICE IS USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. IF IS MOST COMMONLY RELATED TO THE PATIENT¿S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR¿S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. FACTORS SUCH AS TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT MAY CONTRIBUTE TO IT. IN THIS CASE, VESSEL CHARACTERISTICS ARE UNKNOWN. HOWEVER, IT IS POSSIBLE THAT VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS (GREAT DIFFICULTY ENGAGING THE RIGHT CORONARY ARTERY) MAY HAVE LEAD TO THE REPORTED KINK AND ULTIMATELY WITHDRAWAL DIFFICULTY OF THE DEVICE. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, AND WITHOUT DEVICE RETURN OR DHR, THE REPORTED ISSUE DOES NOT APPEAR TO BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, THE FOLLOWING ARTICLE WAS NOTED: SUCCESSFUL REMOVAL OF AN ENTRAPPED AND KINKED CATHETER DURING RIGHT TRANSRADIAL CARDIAC CATHETERIZATION BY SNARING AND UNWINDING THE CATHETER VIA FEMORAL ACCESS, CARDIOVASCULAR REVASCULARIZATION MEDICINE 13 (2012)202.E1-202.E3 BY KHOUBYRARI ET AL. AS REPORTED, THERE WAS GREAT DIFFICULTY ENGAGING THE RIGHT CORONARY ARTERY WITH AN UNKNOWN CORDIS 5-FR JR5 CATHETER. DURING REPEATED ATTEMPTS, THERE WAS A SUDDEN LOSS OF AORTIC PRESSURE TRACING, AND ATTEMPTS AT ASPIRATING BLOOD THROUGH THE CATHETER LUMEN WERE UNSUCCESSFUL. FLUOROSCOPY OF THE RIGHT FOREARM DEMONSTRATED A 360° KINKED LOOP IN THE CATHETER. MULTIPLE ATTEMPTS AT ADVANCING A WIRE (0.035¿ J-WIRE AND AN ANGLED TIP GLIDE WIRE) THROUGH THE CATHETER LUMEN IN HOPES OF UNKINKING THE CATHETER FAILED. IN ADDITION, WE WERE UNABLE TO ADVANCE, WITHDRAW, OR MANIPULATE THE CATHETER DESPITE ADMINISTERING MULTIPLE ANTI-SPASM MEDICATIONS. THE DECISION WAS MADE TO OBTAIN FEMORAL ACCESS WITH THE GOAL OF SNARING AND REMOVING THE CATHETER. UTILIZING A MODIFIED SELDINGER'S TECHNIQUE, A 7-FR SHEATH (CORDIS CORPORATION) WAS PLACED INTO THE RIGHT COMMON FEMORAL ARTERY. A 7-FR EN SNARE CATHETER (MERIT MEDICAL SYSTEMS) WAS ADVANCED INTO THE AORTIC ARCH AND WAS USED TO CAPTURE THE DISTAL END OF THE JR5. SUBSEQUENTLY, BY GENTLY PULLING AND ROTATING THE DISTAL END OF THE JR5 WITH THE EN SNARE CATHETER, WHILE SIMULTANEOUSLY ROTATING AND PULLING THE HUB OF THE JR5 CATHETER IN THE OPPOSITE DIRECTION, WE WERE ABLE TO UNKINK AND REMOVE THE CATHETER THROUGH THE RADIAL SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170298 DIAGNOSTIC CARDIOLOGY CATHETER- 6F DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R