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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Pericarditis (4448)

Event Date 11/29/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed:di biase l, tabereaux p, liu cf, vasaiwala s, chugh a, saliba wi; surpoint postapproval trial investigators.Reproducibility of paroxysmal atrial fibrillation ablation clinical outcomes using composite ablation index with different contact force-sensing catheters.Circ arrhythm electrophysiol.2022 dec;15(12):e011561.Doi: 10.1161/circep.122.011561.Epub 2022 nov 29.Pmid: 36445824.Objective/methods/study data: us trial included patients treated with stsf.Fifty patients were enrolled in the st patient cohort between april 2019 and june 2020.One patient withdrew from the study; therefore, 49 patients were included in the safety and the effectiveness populations.Baseline patient characteristics were similar to that of the stsf patient cohort with mean age of 62.7 years, 55.1% female, and mean cha2ds2-vasc score of 1.9.3 symptomatic atrial fibrillation duration was slightly lower for the st cohort at 31 months versus 37 months in the stsf group.3.Lot, model and catalog number are not available, but the suspected named biosense device possibly associated with reported adverse events:smarttouch sf.Other named 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 (possibly associated with the suspected device): qty 2 stroke/cerebrovascular accident (one discharged 6 days post index ablation and no neurlogical deficits at 85 day follow up and the other discharched 2 days post ablation with signs of full recovery.Qty 1 pericarditis (intervention not discussed for this patient).

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, tabereaux p, liu cf, vasaiwala s, chugh a, saliba wi; surpoint postapproval trial investigators.Reproducibility of paroxysmal atrial fibrillation ablation clinical outcomes using composite ablation index with different contact force-sensing catheters.Circ arrhythm electrophysiol.2022 dec;15(12):e011561.Doi: 10.1161/circep.122.011561.Epub 2022 nov 29.Pmid: 36445824.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.Catalog should be unk_smart touch bidirectional sf.

• 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: 16573265
• MDR Text Key: 311596856
• Report Number: 2029046-2023-00578
• 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: 03/20/2023

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: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/20/2023
• 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): Hospitalization; Life Threatening