MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Fistula (1862); Pseudoaneurysm (2605); Tissue Breakdown (2681)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: zhou b, zhu yj, zhai zq, weng sx, ma yz, yu fy, qi yj, jiang yz, gao x, xu xq, jiang x, jing zc, tang m.Radiofrequency catheter ablation of supraventricular tachycardia in patients with pulmonary hypertension: feasibility and long-term outcome.Front physiol.2021 jun 18;12:674909.Doi: 10.3389/fphys.2021.674909.Pmid: 34220537; pmcid: pmc8249814.Objective: supraventricular tachycardia (svt) occurs commonly and is strongly correlated with clinical deterioration in patients with pulmonary hypertension (ph).This study aimed to investigate the feasibility and long-term outcome of radiofrequency catheter ablation (rfca) in ph patients with svt.Methods/study data: consecutive ph patients with svt who were scheduled to undergo electrophysiological study and rfca between september 2010 and july 2019 were included.The acute results and long-term success of rfca were assessed after the procedure.The mean age of the 71 patients was 43.9 +/- 14.9 years, and there was a slight predominance of females (56.3%).The episodes of svt in the included patients were symptomatic with clinical worsening or right ventricular failure.In patients with accessible right heart catheterization (rhc) data, a mean pulmonary artery pressure 25 mmhg at rest was considered to be diagnostic for ph.A total of 71 ph patients (47 diagnosed by rhc and 24 by echocardiography) with svt were ultimately included.Cavotricuspid isthmus-dependent atrial flutter (n d 33, 43.5%) was the most common svt type, followed by atrioventricular nodal reentrant tachycardia (n d 16, 21.1%).Of the 71 patients, 60 (84.5%) underwent successful electrophysiological study and were subsequently treated by rfca.Among them, acute sinus rhythm was restored in 54 (90.0%) patients, and procedure-related complications were observed in 4 (6.7%) patients.A total of 60 patients underwent rfca treatment, of which 54 patients received successful ablation while 6 did not, yielding a rate of acute sinus rhythm restoration of 90%.All 71 patients were accordingly classified into a successful rfca group (n = 54), a failed rfca group (n = 6), and a non-rfca group (n = 11).The findings suggest that rfca of svt in ph patients is feasible and has a good long-term success rate.Cavotricuspid isthmus-independent atrial flutter and a wider pad could increase the risk for ablation failure.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool navi-star irrigation catheter for patients with focal atrial tachycardia or atrial flutter.Thermocool smart touch irrigation catheter for patients with focal atrial tachycardia or atrial flutter.Other biosense webster devices that were also used in this study: carto 3d mapping.Non-biosense webster devices that were also used in this study: non-irrigated ablation catheter (triguy or safire) for patients with avnrt or avrt irrigation catheter (flexability/tacticath) for patients with focal atrial tachycardia or atrial flutter navx ensite ve.Locity 3d mapping.Adverse event(s) and provided interventions: of note: the authors used ablation catheters from 4 different manufacturers, chosen at random, but did not provide information to associate the following adverse events with specific device manufacturers.The actual number of bwi devices associated with these events is unknown.4 patients in the rfca group experienced adverse events.One patient with avnrt experienced a third-degree atrioventricular block treated with the implantation of a pacemaker but will be excluded from this complaint as the patients with avnrt were treated with competitor non-irrigated catheters.The remaining 3 adverse events are as follows: 1 patient experienced a stroke.The patient had an atrial septal defect with left to right shunting and experienced atrial flutter localized to the left atrium during ablation.The procedure was prolonged while the surgeon administered heparin per standard protocol.The patient subsequently experienced a procedure related stroke confirmed by ct scan.Treatment was not specified but the authors note the patient had good functional recovery with minimal residual left lower extremity deficits.1 patient experienced a 2mm arteriovenous fistula treated with normal compression that occluded spontaneously during follow-up.1 patient with femoral artery pseudoaneurysm.Conservative treatment was unsuccessful, and the patient was eventually surgically treated with a percutaneous balloon occlusion for successful closure.".

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: CARDIAC ABLATION CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12394333
• MDR Text Key: 273559164
• Report Number: 2029046-2021-01455
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• 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
• Patient Outcome(s): Required Intervention