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 Stroke/CVA (1770); Transient Ischemic Attack (2109); Pericardial Effusion (3271); Asystole (4442); Heart Block (4444)

Event Date 05/12/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: cheng c, xu b, sheng j, huang z, he f, gao f, wang x.Procedural efficiency, efficacy, and safety of high-power, short-duration radiofrequency ablation delivered by stsf catheter for paroxysmal atrial fibrillation.Evid based complement alternat med.2022 aug 8;2022:6009275.Doi: 10.1155/2022/6009275.Pmid: 35979002; pmcid: pmc9377865.Objective/methods/study data: this study aims to compare the mapping efficacy, instant success, and long term recurrence of catheter ablation for pacs with non-pulmonary vein (pv) and non-superior vena cava (svc) origins between the novel dual-reference approach (dra) and the routine single-reference approach (sra) of mapping.Patients with symptomatic, drug-refractory pacs, or frequent residual pacs after atrial tachyarrhythmia ablation were enrolled.During activation mapping, the coronary sinus (cs) catheter was used as the only timing reference in the sra group.In the dra group, another catheter, which was spatially separated from the cs catheter, was used as the second reference.The timing difference between the two references was used to discriminate the targeted pacs from the uninterested rhythms.Procedural parameters and long-term recurrence were compared.A total of 188 patients (109 in sra and 79 in dra) were enrolled.Patients with atrial tachyarrhythmias who underwent catheter ablation between january 2015 and january 2020 in xinhua hospital were retrospectively screened (n=3003).Patients underwent ablation of af (n=2215), atrial flutter (afl, n=351), and sustained atrial tachycardia (at, n=120) without frequent residual pacs were excluded.The remaining 317 patients underwent ablation of pacs or non-sustained focal at, including 218 symptomatic patients with drug refractory, frequent pacs, or short runs of at and 99 patients with frequent residual pacs after af, afl, or at ablation in the same procedure lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch, biosense webster, diamond bar, ca, usa other biosense webster devices that were also used in this study: carto, pentaray non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions: qty 3- pericardial effusion (2 in the sra group, and 1 in the dra group )- no intervention mentioned.Qty 1- sinus asystole ( in the sra group)- no intervention mentioned.Qty 2- atrioventricular block ( 1 in the sra group, and 1 in the dra group) - no intervention mentioned.Qty 1- transient ischaemic attack ( dra group) - no intervention mentioned.Qty 1 -ischaemic stroke ( in the sra group)- no intervention mentioned.

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: cheng c, xu b, sheng j, huang z, he f, gao f, wang x.Procedural efficiency, efficacy, and safety of high-power, short-duration radiofrequency ablation delivered by stsf catheter for paroxysmal atrial fibrillation.Evid based complement alternat med.2022 aug 8;2022:6009275.Doi: 10.1155/2022/6009275.Pmid: 35979002; pmcid: pmc9377865.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15613329
• MDR Text Key: 301822433
• Report Number: 2029046-2022-02547
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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: 09/28/2022
• 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; PENTARAY
• Patient Outcome(s): Required Intervention; Life Threatening