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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 07/28/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: hartl s, makimoto h, gerguri s, clasen l, kluge s, brinkmeyer c, schmidt j, rana o, kelm m, bejinariu a.Wide antral circumferential re-ablation for recurrent atrial fibrillation after prior pulmonary vein isolation guided by high-density mapping increases freedom from atrial arrhythmias.J clin med.2023 jul 28;12(15):4982.Doi: 10.3390/jcm12154982.Pmid: 37568384; pmcid: pmc10419947.Objective/methods/study data: the aim of this single-center study was to evaluate the benefit of waca pv re-ablation (re-waca) guided by three-dimensional (3d) high-density left atrial mapping (hdm) as compared to simple ostial re-pvi guided by a circular mapping catheter in patients who experienced af recurrences due to true pv reconnection or an exclusive documentation of residual antral pv potentials within the initial ablation line (without intra-pv potentials) after previous pvi.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch (both groups).Other biosense webster devices that were also used in this study: carto mapping system(both groups), pentaray mapping catheter(in the re-waca group), lasso mapping catheter (in the historical re-pvi control group).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified smarttouch ablation catheter: qty 1 pericardial tamponade (cardiac tamponade) requiring drainage (recognized procedural complication) - occurred on (b)(6) 2018.Qty 1 small intracranial bleeding managed conservatively (minor injury) - authors provide via email response: the interventions were monitoring of vitals, adjustment of the antihypertensives and anticoagulants.Occurred on (b)(6) 2016.Authors provide information this case was high weight for low height (86kg, 147cm).Authors report there are no other adverse events that are associated with use of biosense webster devices within the study group.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: hartl s, makimoto h, gerguri s, clasen l, kluge s, brinkmeyer c, schmidt j, rana o, kelm m, bejinariu a.Wide antral circumferential re-ablation for recurrent atrial fibrillation after prior pulmonary vein isolation guided by high-density mapping increases freedom from atrial arrhythmias.J clin med.2023 jul 28;12(15):4982.Doi: 10.3390/jcm12154982.Pmid: 37568384; pmcid: pmc10419947.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 the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• 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: 17950995
• MDR Text Key: 325898686
• Report Number: 2029046-2023-02339
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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: 09/21/2023
• 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
• Treatment: CARTO MAPPING SYSTEM; LASSO MAPPING CATHETER; PENTARAY MAPPING CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening