CORTRAK* 2 ENTERAL ACCESS SYSTEM
Report
- Report Number
- 3006646024-2018-00028
- Event Type
- Death
- Date Received
- July 12, 2018
- Report Date
- July 12, 2018
- Manufacturer
- HALYARD HEALTH
- Product Code
- KNT
- UDI-DI
- 10680651472011
- PMA / PMN Number
- K113351
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
ALL INFORMATION REASONABLY KNOWN AS OF 02-AUG-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).
THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 10-JUL-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. [(B)(4)]. THE DEVICE WAS NOT RETURNED.
ADDITIONAL INFORMATION RECEIVED 12-JUL-2018 FROM THE PUBLICATION AUTHORS STATED THE INCIDENT WAS NOT PREVIOUSLY REPORTED. IT IS UNCLEAR AS TO THE EXACT DATE, IT WAS NOTED TO BE APPROXIMATELY 10-MONTHS AGO. THE PHYSICIAN REPORTED HE DOES NOT BELIEVE THE PATIENT'S OUTCOME WAS RELATED TO THE NASOGASTRIC TUBE (NGT) PLACEMENT INCIDENT.
A PUBLICATION RECEIVED (THE CASE OF THE MALPOSITIONED FEEDING TUBE¿ WHILE IN PLAIN SIGHT; BY THOMAS LYNCH V, BRIAN T. WESSMAN; REFERENCE-CRIT CARE SHOCK (2018) 21:47-52). THE PUBLICATION DID NOT GIVE AN EVENT DATE WHEN PRESENTING THE CASE: PATIENT WS IS A (B)(6)-YEAR-OLD MALE WHO PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH A CHIEF COMPLAINT OF PROGRESSIVE SHORTNESS OF BREATH (SOB) OVER THE PAST TWO WEEKS. ASSOCIATED SYMPTOMS AT TIME OF PRESENTATION INCLUDED ACUTE BILATERAL LOWER EXTREMITY EDEMA, ORTHOPNEA, AND PAROXYSMAL NOCTURNAL DYSPNEA. HIS PAST MEDICAL HISTORY WAS SIGNIFICANT FOR DIABETES MELLITUS TYPE II, HYPERTENSION, HYPOTHYROIDISM, PAROXYSMAL ATRIAL FIBRILLATION, PAROXYSMAL VENTRICULAR FIBRILLATION, NON-ISCHEMIC CARDIOMYOPATHY (EJECTION FRACTION OF 25%), SEVERE MITRAL VALVE REGURGITATION, AND NEWLY DIAGNOSED ADENOCARCINOMA OF THE COLON. THE PATIENT¿S SURGICAL HISTORY WAS SIGNIFICANT FOR BI-VENTRICULAR ICD PLACEMENT AND GASTRIC SLEEVE SURGERY. HE WAS ADMITTED TO THE HOSPITAL FROM THE ED FOR ACUTE ON CHRONIC HEART FAILURE. DURING HIS HOSPITAL COURSE, HE WAS DEEMED A SURGICAL CANDIDATE FOR HIS COLON CANCER WITH PLANNED RESECTION. HOWEVER, IT WAS FELT THAT HE NEEDED MEDICAL OPTIMIZATION FOR HIS HEART FAILURE (ADMISSION ECHO SHOWING A DIMINISHED EJECTION FRACTION OF APPROXIMATELY 16% WITH BIVENTRICULAR WALL MOTION ABNORMALITIES). HIS HOSPITAL COURSE INCLUDED PLACEMENT OF AN IMPELLA VENTRICULAR ASSIST DEVICE FOR HIS SEVERE HEART FAILURE ON HOSPITAL DAY (HD) 9. THIS WAS THEN CONVERTED TO A HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (LVAD), ON HD 14. THE LVAD PLACEMENT WAS COMPLICATED BY ANEMIA OF ACUTE BLOOD LOSS, INNOMINATE VEIN INJURY, A BRIEF CARDIAC ARREST, AND RIGHT HEART FAILURE. DURING HIS OPERATIVE CASE, HE HAD RIGHT-SIDED EXTRA-CORPOREAL MEMBRANE OXYGENATION (RECMO) PLACED FOR HIS ACUTE ON CHRONIC RIGHT SIDED HEART FAILURE. HIS RECMO CIRCUIT WAS. EVENTUALLY EXCHANGED TO AN EXTERNAL RIGHT VENTRICULAR ASSIST DEVICE (RVAD). DURING HIS PROLONGED ICU STAY, THE PATIENT REGAINED MENTAL STATUS AND WAS FOLLOWING COMMANDS. WS UNDERWENT TRACHEOSTOMY FOR HIS PROLONGED RESPIRATORY FAILURE AND INABILITY TO WEAN FROM VENTILATOR. THROUGHOUT HIS ICU STAY, HE REMAINED ON CONTINUOUS RENAL REPLACEMENT THERAPY FOR ACUTE KIDNEY FAILURE. ON HD 42 HE UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) TO EVALUATE HIS RIGHT HEART FUNCTION. DURING THIS PROCEDURE, HIS DOPPOFF FEEDING TUBE WAS REMOVED PER STANDARD PRACTICE TO FACILITATE TEE PROBE PLACEMENT. AFTER THE TEE PROCEDURE, HIS ENTERAL ACCESS (DOPPOFF FEEDING TUBE) WAS REPLACED USING CORTRAK TECHNOLOGY WITH CONFIRMATION BY CONVENTIONAL CHEST RADIOGRAPHY (CXR). THE CORTRAK IMAGES WERE NORMAL FOR GASTRIC PLACEMENT (FIGURE 1); HOWEVER, DID NOT DEMONSTRATE PROGRESSION INTO THE SMALL BOWEL (STYLET CROSSING MIDLINE). A CONFIRMATORY CXR (PER ICU STANDARD PROTOCOL), REVIEWED BY A JUNIOR-LEVEL HOUSESTAFF, WAS MISINTERPRETED AS ADEQUATE GASTRIC PLACEMENT WITH A CONFIRMATORY NURSING ORDER PROVIDED TO USE THE GASTRIC TUBE. FURTHER REVIEW OF THE CXR CLEARLY DEMONSTRATES THE DOPPOFF ENTERAL ACCESS TUBE IN THE LEFT LOWER LOBE (FIGURE 2). SUBSEQUENTLY, THE PATIENT RECEIVED A SMALL AMOUNT OF LIQUID MEDICATION THROUGH THE TUBE AND SUBSEQUENTLY BEGAN TO DESATURATE. ON INITIAL EVALUATION WITH BEDSIDE SURFACE ECHOCARDIOGRAM, HE WAS FOUND TO HAVE AN UNDER-FILLED LEFT VENTRICLE AND DILATED RIGHT VENTRICLE. AFTER ADJUSTMENT OF THE RVAD FLOW, THE PATIENT REMAINED HYPOXIC, AND AN EMERGENT BRONCHOSCOPY WAS PERFORMED. AT THE TIME OF BRONCHOSCOPY, THE ICU TEAM WAS UNDER THE IMPRESSION THAT THE DOPPOFF WAS APPROPRIATELY POSITIONED IN THE STOMACH. BRONCHOSCOPY FINDINGS INCLUDED VISUALIZATION OF THE FEEDING TUBE IN THE LEFT LUNG WITH LARGE LEFT MAIN STEM BRONCHUS PLUG (FIGURE 3). THE DOPPOFF WAS IMMEDIATELY REMOVED. AGGRESSIVE MEASURES WERE INSTITUTED FOR LAVAGE AND REMOVAL OF THE EXTENSIVE MUCUS PLUG BURDEN. OVER THE NEXT SEVERAL DAYS, WS CONTINUED TO SUFFER FROM HIS ONGOING MULTISYSTEM ORGAN FAILURE. CONTINUED GOALS OF CARE DISCUSSIONS WERE HELD WITH FAMILY MEMBERS WITH A SUBSEQUENT DECISION MADE TO TRANSITION TO COMFORT CARE. WS SUBSEQUENTLY PASSED AWAY. ENTERAL ACCESS IS A COMMON NECESSITY IN THE CRITICALLY ILL PATIENT, WITH AN ESTIMATED 1.2 MILLION STYLETED FEEDING TUBES PLACED EVERY YEAR IN THE UNITED STATES. THE BLIND PLACEMENT OF ENTERAL FEEDING TUBES IS A DAILY PRACTICE IN THE ICU SETTING. ONE OF THE MOST COMMON COMPLICATIONS IS MISPLACEMENT, SPECIFICALLY IN THE TRACHEOBRONCHIAL TREE. THIS OCCURS ABOUT 1.9% OF THE TIME. (2) RASSIAS AND COLLEAGUES LOOKED AT 740 PATIENTS WITH A SIMILAR COMPLICATION RATE, AND 2/14 (14%) HAD THE CONFIRMATORY CHEST X-RAY MISREAD. CORTRAK IS A U.S. FOOD DRUG AND ADMINISTRATION (FDA) APPROVED DEVICE TO AID IN THE PLACEMENT OF SMALL-BORE STYLETTED FEEDING TUBES INTO THE SMALL BOWEL AND LIMIT THE NEED FOR CONFIRMATORY RADIOGRAPHY. IT USES ELECTROMAGNETIC DETECTION TO TRACE THE PATH OF FEEDING TUBE. THEREFORE, GASTRIC AND PULMONARY PLACEMENT CAN APPEAR SIMILAR (DUE TO THEIR OVERLYING ANATOMICAL PLANES). USING CORTRAK ADDS AN ADDITIONAL LAYER OF PATIENT SAFETY AND ASSISTANCE IN PLACING FEEDING TUBES, HOWEVER IT DOES NOT REPLACE CXR CONFIRMATION. METHENY¿S 2014 REVIEW ARTICLE DEMONSTRATED THAT THERE IS SMALL PERCENTAGE OF CASES WHERE DESPITE CORRECT CORTRAK IMAGES, THE FEEDING TUBE IS MALPOSITIONED. (1) AT THE TIME OF THAT PUBLICATION, THERE WERE 21 CASES IDENTIFIED. FROM THE MAUDE (FDA MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE) DATABASE. OF THESE 21 CASES, AT LEAST 2 HAD THE CXR MISINTERPRETED. BESIDES MALPOSITIONING, THE OVERALL COMPLICATION RATE WITH THE USE OF CORTRAK ALSO INCLUDES 17 SELFREPORTED CASES OF PNEUMOTHORACES IN THE MAUDE DATABASE. AS THIS DATABASE DEPENDS ON SELFREPORTING, IT IS PRESUMED THAT THE OVERALL RATE OF ENTERAL TUBE MISPLACEMENT MAYBE HIGHER. MANY MEDICAL MYTHS HAVE BEEN PROPAGATED ABOUT CONFIRMATION OF NASOGASTRIC TUBE (NGT) PLACEMENT. ONE MAJOR MYTH INCLUDE INSUFFLATION FOR CONFIRMATION AND ASPIRATION OF FLUID, BOTH WHICH HAVE BEEN DEMONSTRATED TO BE UNRELIABLE. ANOTHER MAJOR MYTH IS THAT ENDOTRACHEAL INTUBATION WILL PREVENT THE FEEDING TUBE FROM ENTERING THE TRACHEOBRONCHIAL TREE. SOROKIN, ET AL DEMONSTRATED IN A REVIEW OF 187 ENTERAL TUBE MISPLACEMENTS THAT 60.4% WERE PLACED IN PATIENTS WITH CUFFED ENDOTRACHEAL TUBES. THE GOLD STANDARD FOR TUBE PLACEMENT CONFIRMATION IS STILL CONSIDERED CONFIRMATORY RADIOGRAPHY IMAGING REVIEWED BY A SEASONED CLINICIAN. THE MAJOR POINT TO REMEMBER IS THAT WHEN PLACING NGT, WHETHER LARGE BORE SALEM SUMP TUBES OR DOPPOFF TUBES FOR FEEDING, THEY SHOULD BE CONFIRMED WITH RADIOGRAPHIC IMAGING REVIEWED BY A SEASONED CLINICIAN PRIOR TO INFUSING ANYTHING THROUGH THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524518 | CORTRAK* 2 ENTERAL ACCESS SYSTEM | DH CORTRAK (EAS) | KNT | HALYARD HEALTH | 20-0950 | UNKNOWN | 10680651472011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Death| R |