BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DIAGNOSTIC CARDIOLOGY CATHETER- 5F INFINITI

    MDR report key: 3746309 · Received April 11, 2014

    Report

    Report Number
    9616099-2014-00265
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 21, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THE EVENT DATE OF (B)(6) 2014 IS THE DATE OF PUBLICATION FOR THE ARTICLE. THIS IS ONE OF TWO CASES IDENTIFIED IN THE SAME LITERATURE ARTICLE. PLEASE REFERENCE MFR. REPORT # 9616099-2014-00264 AND #9616099-2014-00265.

    Additional Manufacturer Narrative · 1

    AN ARTICLE BY ZHANG ET AL: ¿A SIMPLE APPROACH FOR THE REDUCTION OF KNOTTED CORONARY CATHETERS DURING TRANSRADIAL CORONARY ANGIOGRAPHY¿ NOTED THAT DURING A CORONARY ANGIOGRAPHY, THERE WAS CONSIDERABLE TORQUEING OF A CORDIS JUDKINS RIGHT CORONARY CATHETER (JR3.5) TO SUCCESSFULLY ENGAGE THE RIGHT CORONARY ARTERY. STANDARD VIEWS WERE THEN TAKEN. UPON ATTEMPTING TO REMOVE THE CATHETER, RESISTANCE WAS ENCOUNTERED. FLUOROSCOPY CONFIRMED THAT THE CATHETER WAS ENTRAPPED AND KINKED ON ITSELF IN THE BRACHIAL SEGMENT. A GUIDEWIRE WAS UNABLE TO PASS THROUGH THE KNOT, AND APPLYING CLOCKWISE OR ANTICLOCKWISE ROTATION OR GENTLE TRACTION WOULDN¿T REDUCE THE KNOT. ADDITIONAL ATTEMPTS TO UNRAVEL THE CATHETER WITH GENTLE ROTATION CAUSED SEVERE FOREARM PAIN. THE CATHETER WAS THEN SUCCESSFULLY RETRIEVED BY USING THE GOOSE NECK SNARE METHOD. AFTER RIGHT FEMORAL ARTERY PUNCTURE, A 6F JR3.5 GUIDING CATHETER WAS USED. THROUGH THE GUIDING CATHETER, AN AMPLATZ GOOSENECK SNARE WAS PASSED AND GRASPED THE KINKED CATHETER TIP IN THE AORTA ARCH. THE ENTRAPPED CATHETER WAS THEN PULLED SIMULTANEOUSLY FROM THE TWO ENDS WITH THE HELP OF THE SNARE, AND THE LOOPED CATHETER WAS STRAIGHTENED. AFTER RELEASING THE SNARE, THE KINKED CATHETER WAS UNRAVELED WITH A 0.35 INCH GUIDEWIRE AND WAS SUCCESSFULLY REMOVED FROM THE RADIAL ARTERY. AFTER ANGIOGRAPHY EXAMINATION, NO STENOSIS WAS FOUND IN THE CORONARY ARTERY. AORTIC VALVE REPLACEMENT AND ASCENDING AORTIC VALVULOPLASTY WERE PERFORMED SUCCESSFULLY ONE WEEK LATER. 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, OR FILMS OF THE EVENT, THE CAUSE OF THE REPORTED CATHETER BODY SHAFT ¿KINKED/BENT IN PATIENT¿ AND ¿WITHDRAWAL DIFFICULTY FROM VESSEL¿ COULD NOT BE CONFIRMED. HOWEVER VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS (CONSIDERABLE TORQUEING) MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND WITHOUT DEVICE RETURN OR DHR, THE REPORTED ISSUE DOES NOT APPEAR TO THE 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 SEARCH, AN ARTICLE WAS NOTED IN THE PUBLICATION BY ZHANG ET AL: ¿A SIMPLE APPROACH FOR THE REDUCTION OF KNOTTED CORONARY CATHETERS DURING TRANSRADIAL CORONARY ANGIOGRAPHY¿, INTERNATIONAL JOURNAL OF CARDIOLOGY 171 (2014) 297-299. DURING A CORONARY ANGIOGRAPHY PRIOR TO VALVE REPLACEMENT, UPON WITHDRAWAL OF A CORDIS JUDKINS RIGHT CORONARY CATHETER (JR3.5), RESISTANCE WAS ENCOUNTERED A KNOT WAS NOTED IN THE BRACHIAL ARTERY. ON FLUOROSCOPY, THE CATHETER WAS FOUND ENTRAPPED AND KINKED ON ITSELF IN THE BRACHIAL SEGMENT. THE GUIDEWIRE COULDN¿T BE ABLE TO PASS THROUGH THE KNOT, AND APPLYING CLOCKWISE OR ANTICLOCKWISE ROTATION OR GENTLE TRACTION COULDN¿T REDUCE THE KNOT. ATTEMPTS TO UNRAVEL THE CATHETER WITH GENTLE ROTATION CAUSED SEVERE FOREARM PAIN. THUS, THE CATHETER COULD NOT WITHDRAW FROM THE BRACHIAL ARTERY USING THE REGULAR MANEUVERS. THE CATHETER WAS SUCCESSFULLY RETRIEVED BY USING THE GOOSE NECK SNARE AND THE PROCESS WAS AS FOLLOWS. AFTER RIGHT FEMORAL ARTERY PUNCTURE, A 6F JR3.5 GUIDING CATHETER WAS USED. THROUGH THE GUIDING CATHETER, AN AMPLATZ GOOSENECK SNARE WAS PASSED AND GRASPED THE KINKED CATHETER TIP IN THE AORTA ARCH. THE ENTRAPPED CATHETER WAS THEN PULLED SIMULTANEOUSLY FROM THE TWO ENDS UNDER THE HELP OF THE SNARE, AND THE LOOPED CATHETER WAS STRAIGHTENED. AFTER RELEASING THE SNARE, THE KINKED CATHETER WAS UNRAVELED WITH A 0.35 INCH GUIDEWIRE AND WAS SUCCESSFULLY REMOVED FROM THE RADIAL ARTERY. NO STENOSIS WAS FOUND IN THE CORONARY ARTERY AFTER ANGIOGRAPHY EXAMINATION. AORTIC VALVE REPLACEMENT AND ASCENDING AORTIC VALVULOPLASTY WERE PERFORMED SUCCESSFULLY ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221385 UNKNOWN DIAGNOSTIC CARDIOLOGY CATHETER- 5F INFINITI DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R AMPLATZ GOOSENECK SNARE