BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 8995055 · Received September 11, 2019

    Report

    Report Number
    3010412492-2019-00001
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 13, 2019
    Manufacturer
    ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL
    Product Code
    PLA
    UDI-DI
    00857915006227
    PMA / PMN Number
    K180244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: ATTUNE MEDICAL CLINICAL EXPERT, DR. (B)(6), WAS CONSULTED ON THE DETAILS SURROUNDING THIS INCIDENT. DR. (B)(6) BELIEVES THE PRESENCE OF BLOOD IN THE NASOGASTRIC TUBE PRIOR TO INSERTION OF THE ENSOETM INDICATES IT IS HIGHLY UNLIKELY THE ENSOETM CAUSED THE STOMACH TEAR. DR. (B)(6) OPINED THAT WHILE THE STOMACH MAY HAVE BEEN DAMAGED DURING PLACEMENT OF THE NASOGASTRIC TUBE, HE BELIEVES THE TEAR IN THE STOMACH WAS MOST LIKELY A STRESS ULCER. STRESS ULCERS ARE RELATIVELY COMMON IN INTENSIVE CARE UNIT (ICU) PATIENTS, SOME OF WHICH CAN CAUSE HEMORRHAGE . AS A CONSEQUENCE, MANY CRITICALLY ILL PATIENTS REQUIRE PROPHYLAXIS FOR PRIMARY PREVENTION OF BLEEDING FROM STRESS ULCERATION OR TREATMENT FOR STRESS ULCER-RELATED BLEEDING. DR. (B)(6) DIRECTLY CONTACTED (B)(6) TO INQUIRE ABOUT THE CAUSE OF THE STOMACH TEAR. (B)(6) STATED THAT THE GI PHYSICIAN WHO PERFORMED THE ESOPHAGOGASTRODUODENOSCOPY BELIEVED EITHER THE ENSOETM OR NASOGASTRIC TUBE COULD HAVE CONTRIBUTED TO THE TEAR AND STATED THAT THE INTENSIVIST BELIEVED THE TEAR WAS CAUSED BY THE NASOGASTRIC TUBE. (B)(6) ADDITIONALLY STATED THAT SHE DOES NOT BELIEVE THE ENSOETM CONTRIBUTED TO THE TEAR. PRODUCTION RECORD INVESTIGATION: PRODUCTION RECORDS FOR LOT #199207119 WERE REVIEWED TO DETERMINE IF ANY DEVIATIONS OR NON-CONFORMANCES OCCURRED DURING MANUFACTURING. MSC1036 ECD SUB-ASSEMBLIES FROM VESTA LOT #637214 WERE USED TO MANUFACTURE LOT #199207119. OUR CONTRACT MANUFACTURER, VESTA INC., PERFORMED A FORMAL REVIEW OF THE MANUFACTURING RECORDS FOR LOT #637214 AND DETERMINED THAT ALL PROCESSES WERE PERFORMED IN ACCORDANCE WITH THE PRODUCTION ROUTER BY TRAINED OPERATORS AND THAT NO DEVIATIONS OR NONCONFORMANCES WERE ISSUED. LABELING INVESTIGATION: THE DHR FOR LOT #199207119 WAS REVIEWED TO DETERMINE THE VERSION OF THE IFU THAT WAS USED TO MANUFACTURE THIS LOT. ECD-155 REV C ECD04-A INSTRUCTIONS FOR USE WAS USED TO MANUFACTURE THIS LOT. ECD-155 REV C CONTAINS THE FOLLOWING WARNINGS/PRECAUTIONS THAT MAY BE RELEVANT TO THIS INCIDENT: "THE ENSOETM MAY CAUSE OR EXACERBATE ESOPHAGEAL TISSUE DAMAGE IN PATIENTS WITH KNOWN ESOPHAGEAL DEFORMITY OR EVIDENCE OF ESOPHAGEAL TRAUMA." AND "DUAL PLACEMENT OF OTHER DEVICES IN THE ESOPHAGUS WITH THE ENSOETM IS AN UNINTENDED USE AND MAY RESULT IN PATIENT HARM." THE ENSOETM WAS PLACED INTO A PATIENT WITH BLOODY OUTPUT FROM THE NASOGASTRIC TUBE, INDICATING AN ACTIVE BLEED SOMEWHERE IN THE GASTROINTESTINAL TRACT. INSERTION OF THE ENSOETM INTO A PATIENT WITH EVIDENCE OF TRAUMA IS A KNOWN RISK, AND CLINICIANS ARE APPROPRIATELY WARNED THAT INSERTION OF THE ENSOETM INTO THESE PATIENTS MAY CAUSE ADDITIONAL HARM. FURTHERMORE, THE ENSOETM WAS PLACE ALONGSIDE A NASOGASTRIC TUBE. DUAL PLACEMENT OF DEVICES IN THE ESOPHAGUS IS ALSO A KNOWN RISK, AND CLINICIANS ARE WARNED THAT THIS ACTION MAY CAUSE PATIENT HARM. CONCLUSION: THE EXACT CAUSE OF THE STOMACH INJURY IS UNABLE TO BE DETERMINED FROM THE INFORMATION AVAILABLE. BASED ON THE PRESENCE OF BLOOD IN THE NASOGASTRIC TUBE PRIOR TO INSERTION OF THE ENSOETM, IT IS REASONABLE TO CONCLUDE THE INJURY WAS PRESENT PRIOR TO INSERTION OF THE ENSOETM. THE INJURY MAY HAVE BEEN CAUSED BY A STRESS ULCER, IT MAY HAVE BEEN CAUSED OR EXACERBATED BY INSERTION OF THE NASOGASTRIC TUBE, AND/OR IT MAY HAVE BEEN EXACERBATED BY DUAL PLACEMENT OF THE ENSOETM WITH A NASOGASTRIC TUBE. IF THE ENSOETM EXACERBATED THE TEAR, THE CAUSE WAS MOST PROBABLY USER ERROR DUE TO BOTH THE INSERTION OF THE ENSOETM INTO A PATIENT WITH EVIDENCE OF TRAUMA (I.E. BLOODY OUTPUT FROM THE NASOGASTRIC TUBE) AND THE INSERTION OF THE ENSOETM INTO A PATIENT WITH A NASOGASTRIC TUBE ALREADY IN PLACE.

    Description of Event or Problem · 1

    AN END USER REPORTED DISCOVERING A TEAR IN THE PATIENT'S STOMACH FOLLOWING PLACEMENT OF THE ENSOETM. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT IN CARDIAC ARREST ON (B)(6) 2019. THE PATIENT HAD BEEN ON A DANCE FLOOR WHEN HE COLLAPSED. HE RECEIVED BYSTANDER CARDIOPULMONARY RESUSCITATION (CPR) AND RECEIVED TWO SHOCKS FROM AN AUTOMATIC EXTERNAL DEFIBRILLATOR. PARAMEDICS ARRIVED AND PERFORMED EXTENDED CPR, WITH A TOTAL OF SIX ROUNDS OF EPINEPHRINE ADMINISTRATION, A SINGLE DOSE OF 300 MG OF AMIODARONE, AND A TOTAL OF SIX ADDITIONAL SHOCKS. THE PATIENT RECEIVED A RETURN OF SPONTANEOUS CIRCULATION AND WAS TRANSFERRED TO THE LOCAL EMERGENCY DEPARTMENT. IN THE LOCAL EMERGENCY DEPARTMENT, THE PATIENT WAS STARTED ON A CONTINUOUS DRIP OF AMIODARONE, A CENTRAL LINE WAS PLACED, A NASOGASTRIC TUBE WAS PLACED, AND A VASOACTIVE AGENT (LEVOPHED) WAS INITIATED TO PROVIDE BLOOD PRESSURE SUPPORT AND TREAT HYPOTENSION. THE PATIENT WAS THEN TRANSFERRED TO A TERTIARY CARE CENTER FOR A HIGHER LEVEL OF CARE, ARRIVING AT THE TERTIARY CARE HOSPITAL ON (B)(6) 2019 AT 11:30PM. THE PATIENT WAS NOTED TO HAVE SPONTANEOUS MOVEMENTS OF BILATERAL UPPER EXTREMITIES, BUT WOULD NOT RESPOND TO COMMANDS. THE PATIENT'S GAZE WAS NOTED TO BE DEVIATED UPWARDS. A CT SCAN WAS PERFORMED ON THE HEAD WITH NO ACUTE FINDINGS NOTED. THE NASOGASTRIC TUBE PLACED PRIOR TO ARRIVAL AT THE TERTIARY CARE CENTER WAS NOTED TO HAVE BLOODY OUTPUT, AND BRUISING TO THE PATIENT'S TONGUE WAS NOTED. THE PATIENT WAS STARTED ON A PROTON PUMP INHIBITOR (PROTONIX) DRIP, AND HYPOKALEMIA WAS TREATED WITH POTASSIUM INFUSION. VENTILATOR SETTINGS WERE ADJUSTED TO A 40% FRACTION OF OXYGEN, AND URINE OUTPUT WAS NOTED TO BE WITHIN NORMAL EXPECTED LIMITS. THE ENSOETM WAS PLACED (WHILE A NASOGASTRIC TUBE WAS STILL INDWELLED IN THE ESOPHAGUS) TO INITIATE PATIENT COOLING AT 5:45AM ON (B)(6) 2019 AND CONFIRMED WITH X-RAY VERIFICATION. REWARMING WAS INITIATED AT 6:45AM ON (B)(6) 2019. AT 9:30AM ON (B)(6) 2019, SEDATION WAS WEANED, AND THE PATIENT BEGAN TO WAKE UP AND WAS ABLE TO MOVE ALL FOUR EXTREMITIES AND FOLLOW COMMANDS. THE PATIENT PASSED ALL EXTUBATION PARAMETERS. AT THIS TIME, BLEEDING FROM THE NASOGASTRIC TUBE WAS NOTED TO INCREASE, REACHING A VOLUME OF 200 ML. EXTUBATION WAS POSTPONED UNTIL AFTER CONSULT FROM THE GASTROENTEROLOGIST. IN THE MEANTIME, 1 UNIT OF PACKED RED BLOOD CELLS WAS TRANSFUSED. ON (B)(6) 2019, ESOPHAGOGASTRODUODENOSCOPY DISCOVERED THAT THE ESOPHAGUS WAS ENDOSCOPICALLY UNREMARKABLE AND THAT THERE WAS BLOOD WITHIN THE BODY OF THE STOMACH, WITH A CLOT ON A 1.5CM MUCOSAL TEAR WITHIN THE BODY OF THE STOMACH. MINIMAL BLEEDING WAS ENCOUNTERED, THE CLOT WAS REMOVED WITH BIOPSY FORCEPS, AND AN EPINEPHRINE INJECTION OF 5ML INTO THE AREA WAS PERFORMED, WITH THREE CLIPS PLACED TO BRING THE MUCOSA TOGETHER. THE EXAMINED PORTION OF THE DUODENUM WAS OTHERWISE NORMAL. THE PATIENT RECOVERED WITHOUT FURTHER ISSUE AND WAS TRANSFERRED TO ACUTE REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789835 ENSOETM ESOPHAGEAL THERMAL REGULATION DEVICE PLA ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ECD04-A 199207119 00857915006227

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention