MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problem Stroke/CVA (1770)

Event Date 08/31/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed:di biase l, monir g, melby d, tabereaux p, natale a, manyam h, athill c, delaughter c, patel a, gentlesk p, liu c, arkles j, mcelderry ht jr, osorio j; surpoint post approval trial investigators.Composite index tagging for pvi in paroxysmal af: a prospective, multicenter post approval study.Jacc clin electrophysiol.2022 sep;8(9):1077-1089.Doi: 10.1016/j.Jacep.2022.06.007.Epub 2022 aug 31.Pmid: (b)(4).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 not provided by the customer.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.Note: date of death is unknown therefore date of death has been left blank.Note: the literature article's electronic file size is too large to be attached and submitted.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed:di biase l, monir g, melby d, tabereaux p, natale a, manyam h, athill c, delaughter c, patel a, gentlesk p, liu c, arkles j, mcelderry ht jr, osorio j; surpoint postapproval trial investigators.Composite index tagging for pvi in paroxysmal af: a prospective, multicenter post approval study.Jacc clin electrophysiol.2022 sep;8(9):1077-1089.Doi: 10.1016/j.Jacep.2022.06.007.Epub 2022 aug 31.Pmid: (b)(4).Objective/methods/study data: background: visitag surpoint (vs)-guided ablation of paroxysmal atrial fibrillation has demonstrated good short- and long-term success rates with low rates of complications in recent, predominantly european, studies.However, there is a lack of multicenter data from the united states.Objectives: this u.S.Study evaluated the safety and effectiveness of vs ablation using a contact force-sensing catheter for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation.Methods: the prospective, nonrandomized vs post approval study was conducted at 32 u.S.Sites.Ablation consisted of pulmonary vein isolation with recommended vs index targets (anterior, roof, or ridge: 550; posterior or inferior: 380).Additional non-pulmonary vein triggers were ablated at the investigators' discretion.Subjects were followed for 12 months, including a 3-month blanking period.The primary safety endpoint was the primary adverse event rate up to 7 days postablation.The primary effectiveness endpoint was 12-month freedom from atrial tachyarrhythmia recurrence and an additional set of failure modes based on stringent monitoring (weekly transtelephonic monitoring [ttm] [day 91 through month 5], monthly ttm [months 6 to 12], and any symptomatic cardiac episode using ttm, plus electrocardiogram [at discharge, 1 month, 3 months, 6 months, and 12 months] with 24-hour holter monitoring [12 months]).Results: of 283 patients enrolled, 261 had the catheter inserted and underwent ablation (safety cohort); 246 met all eligibility criteria (effectiveness cohort).Mean fluoroscopy time was 2.2 minutes.Mean amount of catheter-delivered fluid was 671 ml; only 18.0% of patients utilized a foley catheter.Primary safety and effectiveness endpoints were met.The raw primary adverse event rate was 4.3% (14 events, n = 11).At 12 months, the kaplan-meier estimate of freedom from primary effectiveness failure was 76.4%; estimates of 12-month freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter recurrence were 81.5% and 92.7% per stringent monitoring and standard-of-care monitoring (excluding ttm), respectively.The first-pass isolation rate was 83.1%, represented by no acute reconnection after the 30-minute waiting period.Freedom from repeat ablation at 12 months was 94.0%.Conclusions: the vs post approval study confirms reproducibility of clinical safety and effectiveness of the standardized vs paroxysmal atrial fibrillation ablation workflow with '80% 12-month freedom from atrial tachyarrhythmia recurrence and first-pass isolation rate of 83.1%.Procedures were performed with minimal fluoroscopy.(evaluation of visitag surpoint¿ module with external processing unit.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events:thermocool stsf ablation catheter other biosense webster devices that were also used in this study:visitag surpoint, qdot, carto3 systm, lasso mapping or pentaray mapping, cartosound.Non-biosense webster devices that were also used in this study: n/a.Ablation parameter details: heparin was provided to achieve an activated clotting time of $(b)(6) seconds during the procedure.Ablation parameters included an rf power range of 15 to 45 w with a cf range of 5 to 25 g for the stsf.The visitag stability recommended settings were 2 to 3 mm across 3 to 5 seconds, with a force over time of 25%.The recommended tag size was 3 mm, and the intertag distance was #6 mm.Adverse event(s) and provided interventions: qty 1 death -possibly related to device and related to procedure.83-year-old woman with a history of paft, cad, dm type 2, and hypothyroidism.This patient underwent the ablation procedure without any device malfunctions or adverse events during the procedure.No clots were found in the left atrial appendage, as confirmed with transesophageal echocardiogram.Post procedure, the patient developed aphasia and right-sided weakness associated with a left middle cerebral artery stroke.Mechanical thrombectomy was performed resulting in reperfusion; however, computerized tomography scans displayed a hemorrhage within the stroke site.The patient did not recover and died 5 days after the study ablation procedure.Qty 4 (3 patients involved) cardiac tamponade/preformation - possibly related to device and related to procedure.None of the events required cardiac surgery.*1 patient had 2 pericardial effusion (day 1 and day 10 post op).Qty 5 (4 patients involved) pericarditis -possibly related to device and related to procedure.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 16433310
• MDR Text Key: 310128207
• Report Number: 2029046-2023-00364
• Device Sequence Number: 1
• Product Code: LPB
• 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: 02/23/2023

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: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 02/23/2023
• 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
• Treatment: CARTO 3 SYSTEM.; CARTOSOUND.; LASSO MAPPING OR PENTARAY MAPPING.; QDOT.; VISITAG SURPOINT.
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Female