BEUDAMED
    FDA Adverse Event Death Summary report: N

    GCB NEEDLE, CATHETER

    MDR report key: 8663765 · Received June 3, 2019

    Report

    Report Number
    1820334-2019-01320
    Event Type
    Death
    Date Received
    June 3, 2019
    Report Date
    August 19, 2019
    Manufacturer
    COOK INC
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DRAWING, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE 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. BASED ON THE REVIEW OF CURRENT DOCUMENTATION, IT WAS CONCLUDED THAT SUFFICIENT CONTROLS AND INSPECTIONS ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO INFORMATION IN THE ARTICLE REGARDING IF THE YUEH CATHETER WAS THOUGHT TO BE RELATED TO THE PSEUDOANEURYSM. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    SUSPECT MEDICAL DEVICE: SPECIFIC PRODUCT INFORMATION CURRENTLY UNAVAILABLE. REPORTED TO REGULATORY AGENCY: UNKNOWN. PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE BELOW EVENT DESCRIPTION WAS FOUND IN THE FOLLOWING ARTICLE: DAY, RYAN W, ERIC A. HUETTL, SAILENDRA G NAIDU, ET AL. "CASE REPORT: SUCCESSFUL COIL EMBOLIZATION OF CIRCUMFLEX ILIAC ARTERY PSEUDOANEURYSMS FOLLOWING PARACENTESIS." VASCULAR AND ENDOVASCULAR SURGERY 48.3 (2014): 262-266. AS STATED IN THE ARTICLE: "A (B)(6)-YEAR-OLD MALE PRESENTED WITH DECOMPENSATING END-STAGE LIVER DISEASE ASSOCIATED WITH HYPONATREMIA, DETERIORATING SERUM CREATININE, AND A MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORE OF 37. HE HAD A PAST MEDICAL HISTORY OF TREATMENT-NAIVE HEPATITIS C (GENOTYPE I, IL-28B CT) COMPLICATED BY ASCITES, HEPATOCELLULAR CARCINOMA, HEPATIC ENCEPHALOPATHY, AND ESOPHAGEAL VARICES. HE HAD AN ABDOMINAL PARACENTESIS AND MICROWAVE ABLATION OF A CAUDATE LOBE LESION PERFORMED 4 DAYS AND 3 WEEKS PRIOR TO THIS PRESENTATION, RESPECTIVELY..." IT WAS FURTHER STATED, "FOLLOWING HOSPITAL ADMISSION AND EVALUATION, ULTRASOUND-GUIDED PARACENTESIS WAS PERFORMED...BY THE PLACEMENT OF AN 18-GAUGE YUEH CENTESIS DISPOSABLE CATHETER NEEDLE (COOK MEDICAL, BLOOMINGTON, INDIANA) INTO THE LARGEST FLUID COLLECTION IN THE RIGHT LOWER QUADRANT OF THE ABDOMEN. APPROXIMATELY 2700 ML OF AMBER FLUID WAS REMOVED." IT WAS FURTHER STATED, "ON THE FOLLOWING DAY, THE PATIENT ACUTELY DETERIORATED COMPLAINING OF SEVERE UPPER ABDOMINAL PAIN. ON EXAMINATION, HE WAS TACHYCARDIC AND A BLOOD PRESSURE OF 85/50 MM HG. HIS HEMOGLOBIN DROPPED SIGNIFICANTLY REQUIRING A BLOOD TRANSFUSION. DESPITE RECEIVING 4 UNITS OF PACKED RED CELLS (PRBCS), HE REMAINED HEMODYNAMICALLY UNSTABLE WITH FURTHER DECLINE IN HEMOGLOBIN. HE REQUIRED ADDITIONAL BLOOD TRANSFUSION PRODUCTS (4 PRBCS AND 2 FRESH FROZEN PLASMA [FFP]) AND WAS COMMENCED ON INOTROPIC SUPPORT WITH DOPAMINE AT 15 MG/KG/H. AN EMERGENCY COMPUTED TOMOGRAPHY (CT) ANGIOGRAM OF THE ABDOMEN AND PELVIS CONFIRMED ACTIVE HEMORRHAGE ADJACENT TO THE PERIHEPATIC REGION OF THE RIGHT UPPER QUADRANT. A TRANSFEMORAL ARTERIOGRAM REVEALED A 6.0 X 8.0 MM PSEUDOANEURYSM ALONG THE RIGHT LATERAL ABDOMINAL WALL ORIGINATING FROM THE DEEP CIRCUMFLEX ILIAC ARTERY... PERCUTANEOUS THROMBIN INJECTION WAS ADMINISTERED INTO THE PSEUDOANEURYSM WITH SUCCESSFUL THROMBOSIS." REGARDING THE PATIENT'S FINAL CONDITION, IT IS STATED THE PATIENT DETERIORATED THE FOLLOWING DAY AND REQUIRED ADDITIONAL BLOOD PRODUCTS AND REPEAT TRANSFEMORAL ARTERIOGRAM WHERE POLYVINYL ALCOHOL (PVA) FOAM EMBOLIZATION PARTICLES (200 MM; COOK MEDICAL, BLOOMINGTON, INDIANA) WERE INJECTED FOLLOWED BY DEPLOYMENT OF 3 COILS (VORTX 18 VASCULAR OCCLUSION COIL, BOSTON SCIENTIFIC, QUINCY, MASSACHUSETTS). POSTEMBOLIZATION ANGIOGRAM DEMONSTRATED SATISFACTORY OCCLUSION OF THE PSEUDOANEURYSM. PATIENT REMAINED STABLE FOR 2 DAYS AT WHICH TIME HE DEVELOPED SIGNIFICANT GASTROINTESTINAL BLEEDING FROM ESOPHAGEAL VARICES. DESPITE EFFORTS FROM HIS MEDICAL TEAM, THE BLEEDING CONTINUED, THE PATIENT FURTHER DETERIORATED, TREATMENT WAS WITHDRAWN AND PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455987 GCB NEEDLE, CATHETER GCB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death