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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is from a literature source.The following literature cite has been reviewed: sebag fa, simeon e, miled m, jorrot p, villejoubert o, darondel jm, hamon d, lellouche n, mignot n.Single-catheter simplified stepwise approach to persistent atrial fibrillation ablation: a feasibility study.Arch cardiovasc dis.2021 oct 4:s1875-2136(21)00136-4.Doi: 10.1016/j.Acvd.2021.06.012.Epub ahead of print.Pmid: 34620575.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.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: sebag fa, simeon e, miled m, jorrot p, villejoubert o, darondel jm, hamon d, lellouche n, mignot n.Single-catheter simplified stepwise approach to persistent atrial fibrillation ablation: a feasibility study.Arch cardiovasc dis.2021 oct 4:s1875-2136(21)00136-4.Doi: 10.1016/j.Acvd.2021.06.012.Epub ahead of print.Pmid: 34620575.Objective/methods/study data:to evaluate the feasibility of this approach to performing persistent atrial fibrillation ablation, including pulmonary vein isolation and atrial lines, if needed.Included 159 consecutive patients referred to the centre for a first persistent atrial fibrillation ablation between january 2018 and december 2018.All patients underwent pulmonary vein isolation.If the patient was still in atrial fibrillation (spontaneously or inducible), authors subsequently performed a stepwise approach, including roof line, anterior mitral line, posterior box lesion and cavotricuspid isthmus line.Finally, if patient remained in atrial fibrillation at the end of the procedure, a synchronized direct-current cardioversion was applied to restore sinus rhythm.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf (mapping and ablation) 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: (qty 1 ) stroke/tia - interventions and further details not discussed (qty 20) pericardial effusion/tamponade - interventions and further details not discussed.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12833324
• MDR Text Key: 283487487
• Report Number: 2029046-2021-01991
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/17/2021

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: 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: 10/25/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening