BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 8582893 · Received May 6, 2019

    Report

    Report Number
    1820334-2019-00985
    Event Type
    Injury
    Date Received
    May 6, 2019
    Report Date
    July 15, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CANNOT BE TRACED TO THE DEVICE AND IS LIKELY DUE TO THE PATIENT¿S CONDITION. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = PRE-AMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, A (B)(6) MALE PATIENT WITH A HISTORY OF BILATERAL RETINOBLASTOMA, WEIGHING (B)(6), DEVELOPED VASOSPASM DURING A PROCEDURE TO ADMINISTER INTRA-ARTERIAL CHEMOTHERAPY (IAC). AN UNKNOWN 4 FRENCH COOK MICROPUNCTURE KIT (INCLUDING A 21-GAUGE NEEDLE, 0.018-INCH NITINOL MICROWIRE, DILATOR, 0.035-INCH GUIDE WIRE AND 4-F SHEATH) WAS REPORTEDLY USED TO OBTAIN RIGHT FEMORAL ACCESS DURING THE PROCEDURE, AFTER THE INDUCTION OF GENERAL ENDOTRACHEAL ANESTHESIA AND PHARMACOLOGIC PARALYSIS. A WARMING BLANKET WAS USED TO MAINTAIN NORMAL TEMPERATURE, AND PULSE OXIMETRY WAS MONITORED ON THE RIGHT GREAT TOE. ONCE ACCESS WAS OBTAINED, THE 0.018-INCH WIRE GUIDE WAS ADVANCED THROUGH THE MICROPUNCTURE NEEDLE WITHOUT RESISTANCE. FLUOROSCOPY WAS USED TO CONFIRM THE ARTERIAL ENTRY SITE, WHICH SUGGESTED THAT THE WIRE HAD PASSED INTO A SIDE BRANCH, THOUGHT TO BE THE INFERIOR EPIGASTRIC ARTERY (IEPA). RESISTANCE WAS ENCOUNTERED WHEN THE USER ATTEMPTED TO PULL THE WIRE BACK. A SECOND ATTEMPT TO REMOVE THE WIRE A FEW MINUTES LATER WAS ALSO UNSUCCESSFUL. THE USER WAITED 20 MINUTES TO ALLOW FOR RESOLUTION OF THE SUSPECTED VASOSPASM PRIOR TO ANOTHER ATTEMPT AT REMOVAL. THE MICROPUNCTURE NEEDLE WAS REMOVED AND HEMOSTASIS OBTAINED. THE INNER DILATOR OF THE MICROPUNCTURE SET WAS INTRODUCED INTO THE FEMORAL ARTERY OVER THE WIRE AND ADVANCED INTO THE ORIGIN OF THE IEPA TO SUPPORT WITHDRAWAL; ALTHOUGH THIS WAS NOT SUCCESSFUL. AN UNKNOWN MANUFACTURER¿S HEMOSTATIC VALVE WAS CONNECTED TO THE DILATOR AND LOCAL, INTRA-ARTERIAL NICARDIPINE WAS ADMINISTERED AROUND THE MICROWIRE, INTO THE SPASTIC VESSEL. THE VALVE WAS REMOVED, HEMOSTASIS WAS ACHIEVED, AND TOPICAL 2.5% LIDOCAINE/PRILOCAINE CREAM WAS APPLIED UNDER A STERILE DRESSING. THE IAC PROCEDURE WAS COMPLETED VIA UNEVENTFUL LEFT FEMORAL ARTERY ACCESS USING ANOTHER COOK 4FR MICROPUNCTURE KIT. SYSTEMIC HEPARIN WAS ADMINISTERED AFTER SUCCESSFUL ACCESS WAS OBTAINED, AND THE LEFT FEMORAL SHEATH WAS KEPT IN PLACE AND SET TO A CONTINUOUS HEPARINIZED SALINE FLUSH. THE RIGHT GROIN DRESSING AND TOPICAL CREAM WERE THEN REMOVED, AND ADDITIONAL ¿GENTLE¿ ATTEMPTS AT REMOVING THE WIRE WERE UNSUCCESSFUL. A 3 FR COOK MAYO CATHETER WAS ADVANCED OVER A 0.035 COOK BENTSON WIRE INTO THE RIGHT COMMON ILIAC ARTERY VIA THE LEFT FEMORAL ACCESS. FLUOROSCOPY SHOWED A PATENT RIGHT COMMON FEMORAL ARTERY WITHOUT INJURY. AFTER ANOTHER ATTEMPT AT RETRACTING THE WIRE WAS UNSUCCESSFUL, THE DECISION WAS MADE TO ADMINISTER INTRAVENOUS NITROGLYCERIN. A TRANSDUCER WAS APPLIED TO THE LEFT FEMORAL SHEATH FOR ARTERIAL PRESSURE MONITORING. ATTEMPTS WERE MADE EVERY 10 MINUTES TO REMOVE THE WIRE, USING FLUOROSCOPY. THE NITROGLYCERIN INFUSION WAS INCREASED AFTER EACH FAILED ATTEMPT AT RETRIEVAL, WHILE MAINTAINING HEMODYNAMIC STABILITY. WHEN THE NITROGLYCERIN INFUSION REACHED 5 MCG/KG/MIN, THE WIRE AND DILATOR WERE SUCCESSFULLY REMOVED, AND HEMOSTASIS WAS OBTAINED WITH MANUAL COMPRESSION. THE PATIENT¿S PULSE OXIMETRY REMAINED 100% THROUGHOUT THE PROCEDURE. THE PATIENT EXPERIENCED NO OTHER COMPLICATIONS AND WAS DISCHARGED THE NEXT MORNING. SORTE, D.E., BAKER, L., BITZER S., COULSON, J.D., & PEARL, M. (2014). "MANAGEMENT OF TRAPPED MICROWIRE DURING FEMORAL ARTERIAL ACCESS IN A PEDIATRIC PATIENT." THE EJOURNAL OF THE EUROPEAN SOCIETY OF MINIMALLY INVASIVE NEUROLOGICAL THERAPY (EJMINT TECHNICAL NOTE, 2014: 1451000248). HTTP://WWW.EJMINT.ORG/TECHNICAL-NOTE/1451000248.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377189 DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention