MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed:gautam s, schaller rd, shinn a, cooper jm, winterfield j, payne j, john l, aksu t, vazquez-diaz o, omarov m, futyma p.Occurrence, management, and outcomes of iatrogenic arterial dissection as a complication of catheter ablation.Jacc clin electrophysiol.2022 sep;8(9):1185-1189.Doi: 10.1016/j.Jacep.2022.05.012.Epub 2022 jul 27.Pmid: 36137728.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-00380 for product code unk (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-00382 for product code unk (thermocool® smart touch® sf bi-directional navigation catheter).(3) mfr # 2029046-2023-00383 for product code unk (thermocool® smart touch® sf bi-directional navigation catheter).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed:gautam s, schaller rd, shinn a, cooper jm, winterfield j, payne j, john l, aksu t, vazquez-diaz o, omarov m, futyma p.Occurrence, management, and outcomes of iatrogenic arterial dissection as a complication of catheter ablation.Jacc clin electrophysiol.2022 sep;8(9):1185-1189.Doi: 10.1016/j.Jacep.2022.05.012.Epub 2022 jul 27.Pmid: 36137728.Objective/methods/study data: the study discribes 8 cases of iatrogenic arterial/aortic dissection with retrograde arterial access over 4 years from 10 centers (0.4%-1% incidence varying by site), which is probably underestimated in the absence of routine angiograms.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events:thermocool smarttouch sf for ablation catheter.Other biosense webster devices that were also used in this study: non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: case 3 (figure 7)- 67-year-old female with obesity (bmi 41.3), htn, cad, nicm, and cardiomypothy.A biosense webster pentaray multipolar mapping catheter was advanced via the right femoral artery and was exchanged for a thermocool smarttouch sf irrigated ablation catheter.Patient developed acute aortic dissection extending from the aortic root to the aortic arch which was diagnosed with intraprocedural angiography via new contralateral femoral arterial access and confirmed by computed tomography angiogram.During the procedure, the sentinel finding was inability to recross the aortic valve after catheter exchange.Initial intracardiac echocardiogram did not visualize the dissection.Patient acutely decompensated (hypotension) and was nonresponsive to inotropes and vasopressor agents.Despite initiation of extracorporeal membrane oxygenation, the patient died within 24 hours, because she was deemed a poor surgical candidate for operative repair because of prolonged cerebral ischemic time.Case 4 (figure 2)- 71-year-old female with nicm and severe ischemic cardiomypopathy and bmi of 20.7.With a thermocool smarttouch sf (biosense webster) irrigated ablation catheter advanced via the right femoral artery.Later in the hospitalization, a type b dissection was incidentally noted on a computed tomography of the chest that was ordered to rule out pulmonary embolism for shortness of breath.Patient remained hemodynamically stable-no symptoms noted.The area of dissection was consistent with the approximate location where the ablation catheter d-curve was flexed multiple times to adopt a prolapsed configuration for retrograde left ventricular approach.After consulting vascular surgery, it was decided to proceed with percutaneous intervention.Repeat computed tomography imaging demonstrated successful intervention with no leak.Stable at 53 months via cta.Case 6 - 59-year-old male with cad.Bmi of 38.Patient sustained a dissection to the abdominal aorta to right common femoral artery (thermocool).Repaired through percutaneous endovascular repair.Patient was stable in 2 weeks.Case 7 (figure 3) - 60-year-old male with htn and ischemic cardiomyopathy.Underwent an elective ablation for vt.A thermocool smarttouch irrigated ablation catheter was introduced via right femoral artery access.The catheter encountered resistance at the level of descending abdominal aorta concurrent with patient complain of pain in the right groin/lower abdomen with any minor catheter manipulation.Intraprocedural angiogram revealed aortic dissection extending from the abdominal aorta to the right iliac artery.Patient remained hemodynamically stable -no symptoms noted.Aortic dissection was confirmed by computed tomography angiogram.Patient responded well to conservative management following vascular consultation and remained stable at 2-month follow-up.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16439868
• MDR Text Key: 310231597
• Report Number: 2029046-2023-00382
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female