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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/15/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: li k, xu c, zhu x, wang x, ye p, jiang w, wu s, xu k, li x, wang y, zheng q, wang y, leng l, zhang z, han b, zhang y, qin m, liu x.Multi-centre, prospective randomized comparison of three different substrate ablation strategies for persistent atrial fibrillation.Europace.2023 may 19;25(5):euad090.Doi: 10.1093/europace/euad090.Pmid: 37050858; pmcid: pmc10228617.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 no lot number was 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.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: li k, xu c, zhu x, wang x, ye p, jiang w, wu s, xu k, li x, wang y, zheng q, wang y, leng l, zhang z, han b, zhang y, qin m, liu x.Multi-centre, prospective randomized comparison of three different substrate ablation strategies for persistent atrial fibrillation.Europace.2023 may 19;25(5):euad090.Doi: 10.1093/europace/euad090.Pmid: 37050858; pmcid: pmc10228617.Objective/methods/study data:the optimal strategy for persistent atrial fibrillation (peraf) is poorly defined.We conducted a multicentre, randomized, prospective trial to compare the outcomes of different ablation strategies for peraf.We enrolled 450 patients and randomly assigned them in a 1:1:1 ratio to undergo pulmonary vein isolation and subsequently undergo the following three different ablation strategies: anatomical guided ablation (anat group, n = 150), electrogram guided ablation (egm group, n = 150), and extensive electro-anatomical guided ablation (ext group, n = 150).The primary endpoint was freedom from atrial fibrillation (af) lasting longer than 30 s at 12 months after a single ablation procedure.After 12 months of follow-up, 72% (108) of patients in the ext group were free from af recurrence, as compared with the 64% (96) in the egm group (p = 0.116), and 54% (81) in the anat group (p = 0.002).The ext group showed less af/atrial tachycardia recurrence than the egm group (60% vs.50%, p = 0.064) and the anat group (60% vs.37.3%, p < 0.001).The ext group showed the highest rate of af termination (66.7%), followed by 56.7% in the egm group, and 20.7% in the anat group.The af termination signified less af recurrence at 12 months compared to patients without af termination (30.1% vs.42.7%, p = 0.008).Safety endpoints did not differ significantly between the three groups (p = 0.924).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf(stsf) , thermocool smarttouch(st).Clinician note: the article does not specify which ablation catheter (stsf or smarttouch) is associated with the adverse events.Therefore, the adverse events are captured on the stsf until further information is received to clarify.Other biosense webster devices that were also used in this study: decapolar mapping catheter (biosense webster, diamond bar, ca, usa), pentaray multispline catheter (biosense webster, diamond bar, ca, usa), carto, biosense webster, ca, usa, non-biosense webster devices that were also used in this study: sl1-type swartz sheaths (st.Jude medical, st.Paul, mn, usa).Adverse event(s) and provided interventions: qty 4- pericardial effuison treated conventionally ( conevntionally would mean pericardiocentesis which is the conventional treatment for pericardial effusion) qty 2- transisent ischaemic attack- no intervention mentioned.Qty 1- stroke- no intervention mentioned.Qty 1- acute heart failure- no intervention mentioned.

• 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: 17135617
• MDR Text Key: 317293463
• Report Number: 2029046-2023-01299
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• 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: DECAPOLAR MAPPING CATHETER (BIOSENSE WEBSTER; SL1-TYPE SWARTZ SHEATHS (ST. JUDE MEDICAL); UNK_CARTO 3; UNK_PENTARAY
• Patient Outcome(s): Required Intervention; Life Threatening