BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCB NEEDLE, CATHETER

    MDR report key: 8659850 · Received May 31, 2019

    Report

    Report Number
    1820334-2019-01338
    Event Type
    Injury
    Date Received
    May 31, 2019
    Report Date
    August 13, 2019
    Manufacturer
    COOK INC
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. CONTROLS ARE IN PLACE TO DETECT POTENTIAL FAILURE MODES THAT MAY RESULT IN THE ADVERSE EVENT DESCRIBED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. NONCONFORMING PRODUCT IS NOT SUSPECTED IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE JOURNAL ARTICLE DOES NOT ALLEGE A MALFUNCTION OF THE KELLET NEEDLE, AND IT IS UNCLEAR FROM THE ARTICLE WHETHER OR NOT THE CAUSES OF THESE COMPLICATIONS ACTUALLY OCCURRED DUE TO THE USE OF THE NEEDLE. A MAIN CONTRIBUTING CAUSE OF THE ADVERSE EVENT CANNOT BE ESTABLISHED. 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. INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN. PMA/510(K) #: PREAMENDMENT. (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

    THE BELOW DESCRIPTION OF TENSION HEMOTHORAX FOLLOWING USE OF A COOK KELLETT NEEDLE WAS TAKEN FROM THE FOLLOWING JOURNAL ARTICLE: SUNDAR, GAURAV, PRADESH KUMAR. "TENSION HEMOTHORAX: A RARE COMPLICATION AND HOW TO AVOID IT." J CLIN INTERV RADIOL 1 (2017): 190-191. AS STATED IN THE ARTICLE, "A (B)(6) MAN WAS ADMITTED WITH SHORTNESS OF BREATH AND A PRODUCTIVE COUGH AND DIAGNOSED WITH SEVERE COMMUNITY-ACQUIRED PNEUMONIA. A COMPUTED TOMOGRAPHY (CT) OF THE CHEST SHOWED THAT THE PATIENT HAD A COMPLEX RIGHT-SIDED PLEURAL EFFUSION SUSPICIOUS OF AN EMPYEMA. AS HE WAS NOT RESPONDING TO ANTIBIOTICS, HE WAS REFERRED FOR AN ULTRASOUND GUIDED DRAINAGE OF THE EFFUSION. THE PROCEDURE WAS PERFORMED VIA A POSTERIOR APPROACH USING THE SELDINGER TECHNIQUE. ON INITIAL PLACEMENT OF A KELLETT NEEDLE (COOK) IMMEDIATELY SUPERIOR TO THE RIB BORDER UNDER ULTRASOUND GUIDANCE, FRANK BLOOD WAS ASPIRATED FROM THE PLEURAL CAVITY. THE POSTERIOR APPROACH WAS ABANDONED AND THE KELLETT NEEDLE REMOVED. THE PROCEDURE WAS ABANDONED, AND A CT OF THE CHEST WAS ORDERED. THIS DEMONSTRATED NO EVIDENCE OF ACTIVE HEMORRHAGE, AND THEREFORE THE PATIENT WAS RETURNED TO THE WARD FOR CLOSE OBSERVATION. TWO HOURS LATER, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH SIGNS OF CARDIOPULMONARY COMPROMISE. A BEDSIDE CHEST X-RAY DONE SHOWED A LARGE VOLUME RIGHT-SIDED EFFUSION RESULTING IN MEDIASTINAL SHIFT. AN EMERGENCY THORACOSTOMY WAS PERFORMED AT THE BEDSIDE TO TREAT THE IMMINENT CARDIORESPIRATORY FAILURE. A LARGE QUANTITY OF BLOOD WAS EVACUATED, BUT THE PATIENT REMAINED TACHYCARDIC AND HYPOTENSIVE. AN URGENT CT SHOWED ACTIVE CONTRAST EXTRAVASATION FROM AN INTERCOSTAL ARTERY AT THE SITE OF THE NEEDLE INSERTION. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY (IR) SUITE WHERE AN ANGIOGRAM SHOWED ACTIVE BLEEDING FROM THE RIGHT SEVENTH INTERCOSTAL ARTERY. THIS WAS SUCCESSFULLY EMBOLIZED USING A SEVERAL SMALL MICRO COILS. POST EMBOLIZATION HE WAS MANAGED IN THE CRITICAL CARE UNIT. THERE WAS DIFFICULTY WEANING HIM OFF THE VENTILATOR AND HE REQUIRED A TRACHEOSTOMY." REGARDING THE PATIENT'S OUTCOME, IT WAS FURTHER STATED, "AFTER A PROTRACTED STAY IN THE CRITICAL CARE UNIT AND SUBSEQUENT SURGICAL PLEURAL DECORTICATION, HE GRADUALLY IMPROVED AND WAS DISCHARGED IN A STABLE CONDITION. A CT DONE 6 MONTHS LATER SHOWED A RIGHT-SIDED FIBROTHORAX AND THE PATIENT REMAINS SYMPTOMATICALLY WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454177 GCB NEEDLE, CATHETER GCB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R