BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA

Report

Report Number: 9612164-2024-02815
Event Type: Injury
Date Received: June 14, 2024
Date of Event: July 1, 2023
Report Date: June 14, 2024
Manufacturer: MEDTRONIC MEXICO
Product Code: DWF
PMA / PMN Number: K143083
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VM
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

LITERATURE DETAILS: AUTHORS: BAO, NGUYEN TRUNG MDA; LUAN, VO THANH MDA; LIEM, BUI THANH MDA ,B; NHU, VO HOANG THIEN MSCC; VIET, DO CHAU MDA; TUNG, TRINH HUU MDA; BURZA, SAKIB MD, PHDD,E; THANH, NGUYEN TAT MD, PHD. TITLE: EXTRACORPOREAL LIFE SUPPORT AND CONTINUOUS RENAL REPLACEMENT THERAPY IN A PATIENT WITH ENTEROVIRUS A71 ASSOCIATED CARDIOPULMONARY FAILURE: A CASE REPORT. MEDICINE 103(1):P E36797, JANUARY 05, 2024. DOI: 10.1097/MD.0000000000036797 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

LITERATURE WAS REVIEWED REGARDING EXTRACORPOREAL LIFE SUPPORT AND CONTINUOUS RENAL REPLACEMENT THERAPY IN A PATIENT WITH ENTEROVIRUS A71. THE PATIENT HAD NO UNDERLYING DISEASES UNTIL HOSPITAL ADMISSION. THE PATIENT¿S MAIN SYMPTOMS WERE PERSISTENT HIGH FEVER, VOMITING, MALAISE, MARKEDLY STARTLING JERKS, AND WEAKNESS OF THE UPPER LIMBS. UPON ADMISSION TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU), THE PATIENT WAS ALERT BUT LETHARGIC, THEY HAD MOTTLED SKIN AND PALE MUCOSA, COOL EXTREMITIES, RESPIRATORY RATE OF 70 BREATHS PER MINUTE, INCREASED HEART RATE OF 198 BEATS PER MINUTE (BPM), A BLOOD PRESSURE READING OF 128/78 MM HG, MOUTH ULCERS, UNDETECTED SKIN RASH OR VESICLES, TACHYCARDIA AND MOIST RALES, SOFT ABDOMEN, MUSCLE TONE OF 5/5 IN THE LOWER LIMBS, AND 3/5 IN HER RIGHT ARM AND 5/5 IN HER LEFT ARM. LABORATORY RESULTS ON ADMISSION REVEALED ELEVATED WHITE BLOOD CELL COUNTS 18 × 109/L, NORMAL VALUES FOR HEMATOCRIT, PLATELET COUNT, ELECTROLYTES AND COAGULATION PRO-FILES, BLOOD GLUCOSE 200 MG%, ASPARTATE TRANSAMINASE (AST)49 U/L AND ALANINE TRANSAMINASE (ALT) 15 U/L, SERUM LACTATE5.8 MMOL/L, SERUM CREATININE 47 MOL/L, PROCALCITONIN 0.9 NG/ML, CARDIAC TROPONIN I 7.36 NG/L AND POSITIVE ENTEROVIRUS-A71IGM ELISA-BASED TESTS. ARTERIAL BLOOD GASES ANALYSIS REVEALED PH 7.38, PCO2 11 MM HG; PO2 115 MM HG; BASE E XCESS (BE)-18.4 AND HCO3 6.2 MEQ/L. CHEST RADIOGRAPHY REVEALED BILATERAL PULMONARY INTERSTITIAL CONGESTION. THE PATIENT WAS DIAGNOSED WITH SEVERE HAND-FOOT MOUTH DISEASE CAUSED BY ENTEROVIRUS A71. THE PATIENT WAS INITIALLY MANAGED WITH MECHANICAL VENTILATION, INTR AVENOUS IMMUNOGLOBULIN, INOTROPE (MILRINONE), AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). FOUR HOURS AFTER INITIATING CRRT, THE PATIENT¿S CLINICAL STATUS PROGRESSIVELY DETERIORATED, AND THEY FURTHER DEVELOPED POLYMORPHIC VENTRICULAR TACHYCARDIA WITH 200 BEATSPER MINUTE, AS OBSERVED ON ELECTROCARDIOGRAM (ECG). PHYSICAL EXAMINATION REVEALED A BLOOD PRESSURE OF 70/35 MM HG, CAPILLARY REFILL TIME (CRT) > 3 SECONDS, RESPONSE TO PAIN STIMULUS, PUPILLARY DIAMETER OF 2 MM, AND POSITIVE LIGHT REFLEX. A POINT-OF-CARE CARDIAC ULTRASOUND AT THE BEDSIDE REVEALED A HYPODYNAMIC HEART, NO SIGNS OF CARDIAC EFFUSION, AND A LOW EJECTION FRACTION (EF) OF 30%. MONITORED LABORATORY TESTS SHOWED HUGE INCREASES IN CARDIAC TROPONIN I(>50 NG/L) AND SERUM LACTATE > 13.4 MMOL/L, AND ARTERIAL BLOOD GASES INDICATING PH 7.21, PCO2 21 MM HG, PO2 185 MM HG,BE -19.5 AND HCO3 7.4 MEQ/L. IN ADDITION, CEREBROSPINAL FLUID (CSF) ANALYSIS REVEALED VALUES WITHIN NORMAL REFERENCE RANGES, INCLUDING CSF LACTATE 1.7 MMOL/L, PROTEIN 0.22 G/L, GLUCOSE 3.6MMOL/L, AND WHITE BLOOD CELL COUNT OF 03 CELLS/MM 3. REPEATED CHEST X-RAY SHOWED SUBSTANTIAL PULMONARY INTERSTITIAL CONGESTION AND AN ENLARGED CARDIAC SILHOUETTE. THE PATIENT WAS MANAGED WITH INTRAVENOUS LIDOCAINE, ELECTRICAL CARDIOVERSION, AND VASOPRESSORS (ADRENALIN AND NORADRENALIN). HOWEVER, THEY SHOWED A POOR RESPONSE TO THESE INTERVENTIONS, AND AN ADDITIONAL ECG REVEALED A DISCRETE VENTRICULAR HEART RHYTHM, FOLLOWED BY ASYSTOLE (CARDIAC ARREST). THE PATIENT WAS FURTHER MANAGED WITH CHEST COMPRESSION, CONTINUED LIDOCAINE ADMINISTRATION, AND INCREASED VASOPRESSOR DOSES. SINCE THE PATIENT SHOWED MINIMAL IMPROVEMENT WITH INTENSIVE TREATMENTS AND CRRT, THE PATIENT WAS INDICATED TO UNDERGO VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) IN COMBINATION WITH THE CRRT. SIMULTANEOUSLY, A PACEMAKER WAS SET UP FOR THIS PATIENT BECAUSE OF LIFE-THREATENING VENTRICULAR ARRHYTHMIA REFRACTORY TO INTRAVENOUS LIDOCAINE. EIGHT HOURS AFTER UNDERGOING VA-ECMO, THERE WAS SIGNIFICANT CLINICAL IMPROVEMENT; THE PATIENT PRESENTED WITH A REGULAR SINUS HEART RHYTHM OF 150 BPM, BLOOD PRESSURE OF105/76 MM HG, CRT OF <(><<)> 2 SECONDS, URINE OUTPUT OF 2 ML/KG/H. THE NEUROLOGICAL STATUS IMPROVED, WITH EYE OPENING TO PAIN STIMULUS, A PUPILLARY DIAMETER OF 2 MM, AND A POSITIVE LIGHT REFLEX. VASOINOTROPIC DOSES WERE MARKEDLY TAPERED, AND LIDOCAINE INFUSION WAS CONTINUED AT 20 ¿G/KG/MIN. REPEATED LABORATORY TESTS REVEALED SUBSTANTIAL IMPROVEMENT, AS INDICATED BY TROPONIN I (28 NG/L), SERUM LACTATE 4.4 MMOL/L, AND ARTERIAL BLOOD GASES (PH 7.40, PCO2 21 MM HG, PO2 180 MM HG,BE -7, AND HCO3 16 MEQ/L). HOWEVER, MARKEDLY INCREASED TRANSAMINASE LEVELS WERE OBSERVED, WITH AN AST LEVEL OF 1545U/L AND ALT LEVEL OF 437 U/L. REPEATED POCUS SHOWED AMELIORATED CARDIAC FUNCTION WITH EF 35% ON DAY 1 AND 48% ON DAY 2 AFTER VA-ECMO. ON DAY 5 AFTER VA-ECMO, THE PATIENT WAS FULLY ALERT, HR 140 BPM, BP 110/65 MM HG, CRT <(><<)> 2 SECONDS, URINE OUTPUT AT 2.5 ML/KG/H, IMPROVED CARDIAC FUNCTION (EF52%), AND CHEST RADIOGRAPHY. THEREFORE, PATIENT WAS WEANED OFF VA-ECMO, INOTROPES, AND LIDOCAINE. MONITORED LABORATORY TESTS SHOWED RESULTS WITHIN CLOSELY NORMAL REFERENCE RANGES, REGARDING SERUM LACTATE, TROPONIN I AND LIVER ENZYMES. PCR TESTING OF RECTAL SWABS CONFIRMED ENTEROVIRUS-A71. NOTWITHSTANDING, THE PATIENT FURTHER EXPERIENCED HIGH FEVER WITHIN CREASED LEVELS OF BIOMARKERS, INCLUDING C-REACTIVE PROTEIN 40 MG/DL AND PROCALCITONIN 4.86 NG/ML, AND NEGATIVE BLOOD AND CSF CULTURES. HOWEVER, PCR RESULTS FROM THE BLOOD AND SPUTUM SAMPLES REVEALED THE PRESENCE OF E. COLI, KLEBSIELLASPP., AND STENOTROPHOMONAS MALTOPHILIA. VENTILATED-ASSOCIATED PNEUMONIA AND PICU-ASSOCIATED SEPSIS WERE THE MOST LIKELY DIAGNOSES. THE PATIENT WAS FURTHER TREATED WITH APPROPRIATE INTRAVENOUS ANTIBIOTICS AND FULLY RECOVERED. IN ADDITION, THE PATIENT EXPERIENCED A SIGNIFICANT COMPLICATION OF RUPTURE IN THE RIGHT FEMORAL ARTERY DURING THE CATHETERIZATION PROCEDURE AND UNDERWENT FURTHER MANAGEMENT WITH THE LEFT SAPHENOUS VEIN GRAFT. APPROXIMATELY 1 WEEK AFTER BEING WEANED FROM VA-ECMO, THE PATIENT WAS FULLY ALERT AND ABLE TO WALK INDEPENDENTLY, ALTHOUGH THE PATIENT STILL HAD INTERMEDIATE WEAKNESS IN THE RIGHT ARM WITH A MUSCLE TONE OF 2/5. IMPORTANTLY, ALL LABORATORY TESTS RETURNED TO NORMAL VALUES. RADIOLOGICALLY, MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN REVEALED SMALL NODULAR LESIONS IN THE POSTERIOR MEDULLA OBLONGATA BILATERALLY, MILD DILATATION OF THE BILATERAL VENTRICLES, AND ENLARGEMENT OF THE SUBARACHNOID SPACE. AT WEEK-4 AFTER HOSPITAL ADMISSION, THE PATIENT WAS CLINICALLY STABLE AND DISCHARGED, ALTHOUGH WEAKNESS IN THE RIGHT ARM WAS NOTICEABLE WITH A MUSCLE TONE OF 1/5, WHILE THE REMAINING UPPER AND LOWER LIMBS SHOWED NOR MAL FUNCTION. THE PATIENT WAS RECOMMENDED PHYSIOTHERAPY. A RE-EXAMINATION 1 MONTH AFTER HOSPITAL DISCHARGE SHOWED CONSIDERABLE CLINICAL IMPROVEMENT, AS THE PATIENT COULD USE THEIR RIGHT HAND FOR DRAWING, AND THE MUSCLE TONE OF THE RIGHT ARM IMPROVED TO 4/5. ADDITI ONALLY, THEIR BRAIN MRI FINDINGS REVEALED MARKED IMPROVEMENT, AS INDICATED BY THE REDUCED LESION SIZE IN THE POSTERIOR MEDULLA OBLONGATA. A 12 FR BIO-MEDICUS ARTERIAL CANNULA 12FR WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY (CFA). BASED ON THE AVAILABLE INFORMATION THE RUPTURE IN THE RIGHT FEMORAL ARTERY DURING THE CATHETERIZATION PROCEDURE MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
189214	BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO	DWF	MEDTRONIC MEXICO	96820-112

Patients

Seq	Age	Sex	Outcome	Treatment
1	5 YR	Female	Required Intervention