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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Ischemic Heart Disease (2493)

Event Date 05/01/2022

Event Type  Death  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: frederic sacher, romain tixier, josselin duchateau, benjamin bouyer, ghassen cheniti, hugo marchand, thomas pambrun, nicolas derval, tsukasa kamakura, conrado pedroso balbo, philipp krisai, ciro ascione, hubert cochet, meleze hocini, michel haissaguerre, pierre jais,.May 1, 2022.Unusual lethal complication during scar-related vt ablation: a case of dry tamponade.Volume 19, issue 5, supplement , s504.Doi:https://doi.Org/10.1016/j.Hrthm.2022.03.1185.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: frederic sacher, romain tixier, josselin duchateau, benjamin bouyer, ghassen cheniti, hugo marchand, thomas pambrun, nicolas derval, tsukasa kamakura, conrado pedroso balbo, philipp krisai, ciro ascione, hubert cochet, meleze hocini, michel haissaguerre, pierre jais,.May 1, 2022.Unusual lethal complication during scar-related vt ablation: a case of dry tamponade.Volume 19, issue 5, supplement , s504.Doi:https://doi.Org/10.1016/j.Hrthm.2022.03.1185.Objective/methods/study data: background: scar related ventricular tachycardia (vt) ablation has been shown to be more effective than anti-arrhythmic drugs in patients with ischemic cardiomyopathy (icmp) and recurrent vt.In this particular population, complication rate can be as high as 10%, the most common ones being vascular damage, and pericardial complications.Objective: to identify a rare but severe complication of scar related vt ablation.Methods: na.Results: a 78 yo male with an old inferior and a recent anterior myocardial infarction (lvef= 25%) was referred to our institution for vt ablation due to arrhythmic storm.Cardiac ct scan revealed inferior and anterior wall thinning (inheart technology; figure panel a).Procedure was performed under conscious sedation in a stable patient.Rf energy was delivered at 40 to 50w using a smarttouch st/sf catheter and the carto 3 navigation system (biosense webster).After ct-channel ablation, a non clinical vt was induced.During ablation of this vt on the inferior wall, st segment elevation in inferior leads became apparent, and arterial pressure dropped from 90 to 70mmhg.The patient was asymptomatic.Per-procedure coronary angiography showed no acute lesion and transthoracic echo demonstrated a dry pericardium.Ablation was continued and the patient was transferred to the icu 1 hour later, with arterial pressure stabilized at 70 mm hg.In the icu, hemodynamic suddenly deteriorated 20 minutes after arrival and the patient went into cardiac arrest.After resuscitation, minimal pericardial effusion and clots were seen on tte.Percutaneous pericardial drainage was attempted but failed to restore hemodynamics.The patient was then transferred to the operating room for surgical drainage.The diagnosis of circumferential intramyocardial hematoma contained by the epicardial layer (dry tamponade) was made (figure panel b).Due to the extent of the hematoma, dilaceration of the myocardium and the clinical context, no further resuscitation was attempted and the patient finally died.Conclusion: this diagnosis of dry tamponade is rare in electrophysiology but well known by cardiologists performing chronic total occlusion angioplasty.It needs to be recognized by electrophysiologists at its early phase to avoid lethal outcome using hemodynamic support during the healing process.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch st/sf catheter.Other biosense webster concomitant devices that were also used in this study: carto 3 navigation system (biosense webster).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: a 78-year-old patient suffered: st elevation, cardiac arrest, dry cardiac tamponade ( will be coded as cardiac tamponade), death, and surgical intervention was required.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15298781
• MDR Text Key: 298664760
• Report Number: 2029046-2022-01984
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_CARTO 3
• Patient Outcome(s): Death; Required Intervention