MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: li j, cui s, song h, cui l, yu h, chu y, dong s.A novel stepwise catheter ablation method of the mitral isthmus for persistent atrial fibrillation: efficacy and reproducibility.Bmc cardiovasc disord.2023 sep 15;23(1):466.Doi: 10.1186/s12872-023-03490-7.Pmid: 37715135; pmcid: pmc10504774.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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not provided by the customer.Note: d4.Catalog should be "unk_smart touch bidirectional sf." 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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: li j, cui s, song h, cui l, yu h, chu y, dong s.A novel stepwise catheter ablation method of the mitral isthmus for persistent atrial fibrillation: efficacy and reproducibility.Bmc cardiovasc disord.2023 sep 15;23(1):466.Doi: 10.1186/s12872-023-03490-7.Pmid: 37715135; pmcid: pmc10504774.Objective/methods/study data: objectives this study aimed to introduce and evaluate a novel ablation method of mi.Methods consecutive patients with persistent atrial fibrillation (peaf) that underwent catheter ablation were included.The mi ablation procedure followed a stepwise approach.In step 1, ethanol infusion of the vein of marshall (ei-vom) was performed.In step 2, a ¿v-shape¿ endocardial linear ablation connecting the left inferior pulmonary vein (lipv) to mitral annulus (ma) was performed.In step 3, earliest activation sites(eass) near the ablation line were identified using activation mapping followed by reinforced ablation.In step 4, precise epicardial ablation was performed, with the catheter introduced into the coronary sinus(cs) to target key ablation targets (kats).Results 135 patients with peaf underwent catheter ablation with the stepwise ablation method adopted in 119 cases.Bidirectional conduction blocks were achieved in 117 patients (98.3%).The block rates of every step were 0%, 58.0%, 44.0%, and 92.9%, and the cumulative block rates for the four steps were 0%, 58.0%, 76.5%, and 98.3%, respectively.No patient experienced fatal complications.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf ablation catheter and vizigo sheath.Other biosense webster devices that were also used in this study: decanav catheter, pentaray mapping catheter.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified smarttouch sf ablation catheter: qty 2 (pericardial effusion) with no treatment required (recognized procedural complication).Qty 1 heart failure after the procedure (cardiac failure) and no treatment discussed in article but assumed to require treatment (serious injury).Adverse event(s) and provided interventions possibly associated with unidentified vizigo sheath: qty 1 femoral (hematoma) treatments were not discussed in article but assumed to require treatment (serious injury).Qty 1 femoral pseduoaneurysm (vascular pseudoaneurysm) treatments were not discussed in article but assumed to require treatment (serious injury).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• 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: 18166480
• MDR Text Key: 328477475
• Report Number: 2029046-2023-02694
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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
• Date Manufacturer Received: 10/31/2023
• 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: DECANAV CATHETER; PENTARAY MAPPING CATHETER
• Patient Outcome(s): Life Threatening