MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ACTC2025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fever (1858); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Title: a severe complication of myocardial dysfunction post radiofrequency ablation treatment of huge hepatic hemangioma: a case rep ort and literature review; source: jun gao; 2019; de gruyter publication.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed year 2019, a (b)(6)-year-old female was admitted because regular follow-up images showed an enlarging subcapsular hepatic hemangioma within the past 4 years.The tumor mass was not palpable by physical examination.Contrast-enhanced ct showed a typical hepatic hemangioma in the left medial lobe (10.7 cm×8.2 cm).A consensus that laparoscopic rf ablation was the optimal therapy for the tumor was made by a multidisciplinary panel of experts in hepatobiliary tumor treatment.Two hepatobiliary surgeons performed the laparoscopic procedures.Briefly, the patient was placed supine on the surgical table.Under endotracheal inhalation anesthesia, a 10 mm incision was made at the umbilicus.Following a pneumoperitoneum at 14 mmhg, two additional trocars were placed under the direct laparoscopic vision.The laparoscopic exploration found an approximately 10.7 cm tumor mass bulging from the left medial lobe.Another 10 mm subxiphoid port was created at the midline of abdomen.Under us guidance, the rf probe was introduced into the peritoneal cavity through the subcostal trocars under the direct laparoscopic vision and deployed into the tumor.A cool-tip actc2025 electrode- an internally cooled cluster electrode, and a rf generator (covidien healthcare, ireland) was used for the tumor coagulation.With a 2.5 cm exposed tip, the cool-tip electrodes can produce ablation zones of 3.0 cm with one session of ablation at the maximum power of 200 w within about 3-5 minutes.The tissue impedance was continuously monitored by the monitor in the rf generator throughout the procedure and the power output was adjusted accordingly.The sufficiently abated tumor tissue appeared as hyperechoicity due to the outgassing effect caused by heating in the tissue.The coagulation time was 64 minutes and the total time of surgery was 105 minutes with 8 sessions of ablations in different locations of the tumor.The total blood loss throughout the treatment was 10 ml.After returning to the ward, the patient was given hydration, low-flow oxygen inhalation via the nasal catheter and vital signs were monitored.Four hours after the procedure, the patient developed dyspnea and wheezing with pinkblood-tinged phlegm, fever with the temperature rising to 38.4°c and transient hemoglobinuria.The patient was tachypneic (22 breaths/minute), with a heart rate of 95 beats/minute, blood pressure of 90/60 mmhg, and oxygen saturation of 74 %.Laboratory examinations showed leukocytosis (wbc 14.5×109/l) and significant elevation of cardiac troponin-i (ctni)(3.42 ng/ml) and brain natriuretic peptide (bnp) (2470.5 pg/ml) level.A transthoracic echocardiogram demonstrated a depressed lv systolic function (ejection fraction = 53%) and multiple regional abnormal motions of heart.Chest x-ray showed the butterfly sign of alveolar edema with cardiomegaly.Therapy was initiated immediately to treat the acute heart failure and systemic inflammatory response syndrome (sirs), including high flow oxygen inhalation by face mask, intravenous diuretics, i.V.Methylprednisolone and short-term antibiotic coverage.The patient¿s clinical condition improved in 12 hours and radiographic appearance of pulmonary edema resolved, but continued to complain of shortness of breath along with hypotension.The transthoracic echocardiogram the next day post the rf ablation did not show regional motion abnormalities of lv with the estimated ejection fraction rising to 64%.A repeat transthoracic echocardiogram performed on day 3 demonstrated an ejection fraction of 61%.Seven days after ablation, the patient¿s cardiomegaly disappeared.The ctni level was 0.10 ng/ml and bnp level was 270.0 pg/ml.A chest radiograph showed complete resolution of pulmonary edema without cardiomegaly.The patient was discharged 9 days after ablation without any symptoms and signs and was followed up for 6 months.

• Brand Name: COOL-TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8911900
• Report Number: 1717344-2019-01069
• Device Sequence Number: 285516
• Product Code: GEI
• UDI-Device Identifier: 10884524001197
• UDI-Public: 10884524001197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACTC2025
• Device Catalogue Number: ACTC2025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR