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 Stroke/CVA (1770); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: luo t, chen y, xiong x, cheng g, deng c, zhang j.Efficacy and safety of the vein of marshall ethanol infusion with radiofrequency catheter ablation for the treatment of persistent atrial fibrillation in elderly patients.Front cardiovasc med.2023 dec 7;10:1276317.Doi: 10.3389/fcvm.2023.1276317.Pmid: 38130690; pmcid: pmc10733440.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).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: luo t, chen y, xiong x, cheng g, deng c, zhang j.Efficacy and safety of the vein of marshall ethanol infusion with radiofrequency catheter ablation for the treatment of persistent atrial fibrillation in elderly patients.Front cardiovasc med.2023 dec 7;10:1276317.Doi: 10.3389/fcvm.2023.1276317.Pmid: 38130690; pmcid: pmc10733440.Objective/methods/study data: background: increasing age is a significant risk factor for atrial fibrillation (af) recurrence after catheter ablation (ca).We accomplished this study to evaluate the efficacy and safety of the vein of marshall (vom) ethanol infusion (vom-ei) with ca in elderly patients with persistent af (psaf).Methods: this retrospective observational study included 360 consecutive adult patients with psaf, of which 141 were in the elder group (age =65 years) and 219 were in the younger group (age <65 years), who underwent the vom-ei and radiofrequency ca (rfca) between may 2020 and april 2022.The efficacy endpoint was no recurrence of af within one year after ca.Results: the vom-ei was successfully performed in 90.8% of patients from the elder and 88.6% from the younger group.All patients achieved pvi; 97.9% of patients from the elder and 98.6% from the younger group reached la roof block, and 93.6% of patients from the elder and 95.9% from the younger group achieved mi block.There was no significant difference in 1-year survival without recurrence of af between the two groups (83.0% and 84.5%, respectively).The incidence of complications within 30 days after the procedure from the two groups was low and did not differ significantly.Conclusion: the vom-ei combined with rfca proved to be an effective and safe strategy for treating psaf in elderly and younger patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf ablation catheter concomitant biosense webster devices that were used in this study: pentaray mapping catheter concomitant non-biosense webster devices that were also used in this study: n/a.Ateriovenous fistula is associated with sheaths for femoral access and the article does not discuss/identify sheaths.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch sf ablation catheter: qty 2 acute (cardiac tamponade) (recognized procedural complication).Qty 5 (pericardial effusion) without pericardiocentesis (recognized procedural complication).Qty 3 strokes (cerebrovascular accident) (recognized procedural complication).

• 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: 18943568
• MDR Text Key: 338187968
• Report Number: 2029046-2024-00956
• Device Sequence Number: 1
• Product Code: LPB
• 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,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 02/25/2024
• 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: UNK_PENTARAY.
• Patient Outcome(s): Life Threatening