MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NON NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NON NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: darma a, bertagnolli l, dinov b, torri f, dagres n, bollmann a, hindricks g, arya a.Vt ablation in geriatric patients with structural heart disease: should there still be an age limit? j cardiovasc electrophysiol.2021 mar;32(3):766-771.Doi: 10.1111/jce.14873.Epub 2021 jan 23.Pmid: 33428325.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: darma a, bertagnolli l, dinov b, torri f, dagres n, bollmann a, hindricks g, arya a.Vt ablation in geriatric patients with structural heart disease: should there still be an age limit? j cardiovasc electrophysiol.2021 mar;32(3):766-771.Doi: 10.1111/jce.14873.Epub 2021 jan 23.Pmid: 33428325.Objective: geriatric patients are often underrepresented in large studies.As frailty is becoming an increasing problem, we need to examine the best course of action for this population.This study sought to examine the feasibility and outcome of ablation of ventricular tachycardias (vts) in a contemporary cohort of geriatric patients with structural heart disease (shd).Methods/study data: the authors studied 68 patients with shd undergoing cardiac ablation procedures between 2012 and 2015.The 68 patient were = 75 years old undergoing vt-ablation (men 88%, ischemic cardiomyopathy 77%, electrical storm 72%, mean left ventricular ejection fraction 31%) and divided the cohort into two groups: 75-79 years old (n = 51) and =80 years old (n = 17).The two groups showed similar results regarding noninducibility as ablation endpoint (p =.693), major procedure-related complications (p =.488), and vt-recurrence (p =.882) during the 39-month follow-up.The octogenarians were more likely to have copd, worse nyha class, and an implanted icd compared to the other patients.The authors utilized both bwi and competitor devices to perform the ablation procedures and did not provide patient or device specific results withing the study.This complaint will capture the adverse events associated with the cardiac ablation procedure.The complications associated with patient comorbidities or other surgical procedures will be excluded from this complaint.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: f-type, irrigated tip, thermocool ablation catheter other biosense webster devices that were also used in this study: carto 3 electronic mapping system.Non-biosense webster devices that were also used in this study: large curve agilis; abbott medical.Therapy cool flex catheter (abbott medical).Agilis epi long sheath; abbott medical.Ensite velocity navigation system (abbott medical).Adverse event(s) and provided interventions: (the authors used ablation catheters from 2 different manufacturers but did not provide information to associate the following adverse events with specific device manufacturers.The actual number of bwi devices associated with these events is unknown.) there was 1 periprocedural death.The time and cause of the death is not specified within the text of the article.The authors note that the death was related to the procedure.1 cardiac tamponade- treatment unknown.1 unspecified severe vascular complication treated surgically (captured as vessel perforation).1 embolic stroke- treatment unspecified.4 unspecified vascular complications- treatment unknown (captured as vessel perforation).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) during an internal review on (b)(6)2021, it was noted that on section h10.Additional manufacturer narrative, on the fourth paragraph, the manufacturer name was inadvertently referred to as cerenovus.The correct manufacturer name is biosense webster inc.Therefore, the correct paragraph to include is: 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.

• Brand Name: UNK_THERMOCOOL SF NON NAV
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12591690
• MDR Text Key: 278188307
• Report Number: 2029046-2021-01696
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NON NAV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS EPI LONG SHEATH, ABBOTT MEDICAL; CARTO 3 ELECTRONIC MAPPING SYSTEM; ENSITE VELOCITY NAVIGATION SYSTEM (ABBOTT MEDICAL); LARGE CURVE AGILIS, ABBOTT MEDICAL; THERAPY COOL FLEX CATHETER (ABBOTT MEDICAL)
• Patient Outcome(s): Life Threatening; Required Intervention