MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_LASSO; CARDIAC DIAGNOSTIC CATHETER

Catalog Number UNK_LASSO

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Syncope/Fainting (4411); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/08/2021

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.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: zhang r, wang y, yang m, yang y, wang z, yin x, dong y, yu x, xiao x, gao l, xia y.Risk stratification for atrial fibrillation and outcomes in tachycardia-bradycardia syndrome: ablation vs.Pacing.Front cardiovasc med.2021 jun 8;8:674471.Doi: 10.3389/fcvm.2021.674471.Pmid: 34169100; pmcid: pmc8217458.Objective: catheter ablation of atrial fibrillation is an alternative treatment for patients with tachycardia-bradycardia syndrome (tbs) to avoid pacemaker implantation.The risk stratification for atrial fibrillation and outcomes between ablation and pacing has not been fully evaluated.The purpose of this study was to conduct a large-scale retrospective analysis involving 306 patients with tbs with an average follow-up time of 6 years, to evaluate whether catheter ablation improved the long-term outcome of the patients with tbs compared with cardiac pacing.Methods/study data: a total of 306 patients with tbs were ultimately selected, including 165 patients with pacemaker implantation (pacing group) and 141 patients with catheter ablation (ablation group).In the ablation group, the tbs patients were all diagnosed with paroxysmal atrial fibrillation and received pulmonary vein isolation (pvi) only without addition lesion sets as the ablation strategy.The ablation procedures for this group are as described in a previous study (12).In brief, pv isolation was performed by ablation catheter navistar thermocool 3.5- mm d-f curve with smart touch technology (biosense webster) using contiguous circumferential lesions guided by (lassotm, biosense and webster, inc., ca, usa).Rf energy was applied in a power-controlled mode with a power limited of 35 w (30 w at the posterior wall) and a maximal temperature of 45¿c.At each point, a radiofrequency current was applied until a voltage of <0.1 mv was achieved, with a maximum of 30 s per point.In the pacing group, the tbs patients all had paroxysmal atrial fibrillation and received ddd or dddr pacing, and the procedures were as described by dong et al.The products used in the pacing group were not specified, therefore the results for this group will be excluded from this complaint.The following complications listed are applied to the 141 patients within the ablation group.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar thermocool 3.5- mm d-f curve with smart touch technology ablation catheter lasso dx catheter for guidance other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: 20 cardiovascular related hospitalizations due to bradycardia, tachycardia, heart failure and coronary heart disease ¿ 9 patients hospitalized due to tachycardia underwent pacemaker implantation and 7 patient received a pacemaker for unspecified reasons.3 reports of thrombosis events/stroke treated with anticoagulants.4 reports of heart failure progression- treatment unspecified.7 reports of syncope- treatment unspecified.9 reports of amaurosis (peripheral vascular embolization of the eye) treated with anticoagulants.2 unspecified ¿operative complications¿ treatment unspecified".

• Brand Name: UNK_LASSO
• Type of Device: CARDIAC DIAGNOSTIC 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12393940
• MDR Text Key: 273844030
• Report Number: 2029046-2021-01453
• Device Sequence Number: 1
• Product Code: DRF
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/31/2021
• 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): Other