MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number UNK_NAVISTAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Pneumothorax (2012); Pericardial Effusion (3271); Heart Block (4444)

Event Date 08/24/2018

Event Type  Injury  

Event Description

This complaint is from a literature source.Chen xj, chen yw, dong jz, qiu cg, tao hl, han zy.[efficacy and safety of three-dimensional electroanatomical mapping system for catheter ablation of paroxysmal supraventricular tachycardia in children].Zhonghua xin xue guan bing za zhi.2018 aug 24;46(8):617-621.Chinese.Doi: 10.3760/cma.J.Issn.0253-3758.2018.08.008.Pmid: 30139012.Objective/methods/study data: the aim of the present study to evaluate the efficacy and safety of three-dimensional electroanatomical mapping system for catheter ablation of paroxysmal supraventricular tachycardia (psvt) children.A total of 187 children (119 males and 68 females, aged 5-16 (10.2 ± 3.5) years) who received radiofrequency ablation in the department of cardiology, the first affiliated hospital of zhengzhou university from january 2012 to april 2016 were retrospectively analyzed.Among them, 91 patients received traditional two-dimensional x-ray radiofrequency ablation (two-dimensional ablation group) and 96 patients received radiofrequency ablation guided by three-dimensional mapping system (three-dimensional ablation group).The differences in the success rate, recurrence rate, complications, operation time and radiation dose between the two groups were compared.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar 4 mm ablation catheter coded as unk_navistar other biosense webster devices that were also used in this study: carto , johnson & johnson temperature-controlled ablation catheter non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions.Qty 5- 1st or 2nd atrioventricular (av) block ( 3 in two-dimensional ablation group and 2 in three-dimensional ablation group ) - atrioventricular block was recovered in 1, and for three- dimensional group both recovered within 3 days.Qty 1- pneumothorax,( in two-dimensional ablation group) which was recovered by conservative treatment.Qty 2- subcutaneous hematoma, ( 1 each in two-dimensional ablation group and in three-dimensional ablation group ) one recovered by conservative treatment and the other recovered.Spontaneously.Qty 1- small amount of pericardial effusion, ( in three-dimensional ablation group) recovered spontaneously after conservative treatment.

Manufacturer Narrative

This complaint is from a literature source.Chen xj, chen yw, dong jz, qiu cg, tao hl, han zy.[efficacy and safety of three-dimensional electroanatomical mapping system for catheter ablation of paroxysmal supraventricular tachycardia in children].Zhonghua xin xue guan bing za zhi.2018 aug 24;46(8):617-621.Chinese.Doi: 10.3760/cma.J.Issn.0253-3758.2018.08.008.Pmid: 30139012.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.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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 15627578
• MDR Text Key: 301972977
• Report Number: 2029046-2022-02570
• Device Sequence Number: 1
• Product Code: DRF
• 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: 10/18/2022

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_NAVISTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO; J&J TEMPERATURE-CONTROLLED ABLATION CATHETER
• Patient Outcome(s): Other