MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Edema (2020); Ventricular Fibrillation (2130); Heart Block (4444)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: elewa, ahmad g., et al.¿comparison between local abnormal ventricular activities (lava) elimination vs.Scar-dechanneling as two substrate-based approaches for ablation of scar-related ventricular tachycardia.¿ vol.Vol12, no.Issue05, 2021.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.Manufacturer¿s reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: elewa, ahmad g., et al.¿comparison between local abnormal ventricular activities (lava) elimination vs.Scar-dechanneling as two substrate-based approaches for ablation of scar-related ventricular tachycardia.¿ vol.Vol12, no.Issue05, 2021.Objective/methods/study data: background: substrate-based approaches for ablation of scar-related ventricular tachycardia (vt) can help overcome the challenges of conventional mapping techniques particularly in vt storm patients.Objective: we aimed to compare the outcomes of scar dechanneling vs.Local abnormal ventricular activity (lava) elimination for ablation in our patient cohort who were predominantly presenting with vt storm.Methods and results: in our prospective observational study, we have enrolled 30 consecutive patients (mean age 58.13 years) with scar related vt (90% had vt storm).We used either the scar dechanneling (in 14 patients) or the lava elimination (in 16 patients) method.No significant difference was found between the two groups regarding the median procedure duration (192 vs 157 minutes in the lava and dechanneling groups respectively, p value 0.142), the median number of ablation points (74 points in each group, p value 0.93) or the acute procedural success rate (87.5% and 78.5% in the lava and dechanneling groups respectively, p value 0.642).At 12 months follow up, the overall recurrence rate was comparable in both groups (62.5% and 50% in the lava and dechanneling groups respectively, p value 0.491).Vt storm recurrence was 12.5% in the lava group compared to 35.5% in the dechanneling group (p value 0.404), a relatively good figure considering that at baseline 90% of patients had vt storm.Conclusion: lava elimination and scar dechanneling are two comparable methods regarding efficacy and safety in ablation of scar-related vt.Both have been associated with high acute success rates in vt storm patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: irrigated 3.5-mm tip ablation catheter thermocool, navistar.Other biosense webster concomitant devices that were also used in this study: a quadripolar biosense webster.Carto 3 system version 6.Non-biosense webster concomitant devices that were also used in this study: a quadripolar st.Jude medical.At.Jude ep lab system (workmate claris.Adverse event(s) and provided interventions: (2) patients developed vf requiring immediate defibrillation.(1) pulmonary edema.(1) heart block due to ablation near the his region.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• 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: 14640850
• MDR Text Key: 293852109
• Report Number: 2029046-2022-01237
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 06/08/2022

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 THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM VERSION 6; QUADRIPOLAR BIOSENSE WEBSTER; QUADRIPOLAR ST. JUDE MEDICAL; ST. JUDE EP LAB SYSTEM (WORKMATE CLARIS
• Patient Outcome(s): Life Threatening; Required Intervention