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

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Nerve Damage (1979); Cardiac Perforation (2513); Heart Block (4444)

Event Date 07/27/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: paolo compagnucci, giovanni volpato, umberto falanga, giulia santarelli, michela colonnelli, alessio gasperetti, giulia stronati, laura cipolletta, fabrizio guarracini, giovanni carreras, corrado carbucicchio, claudio tondo, michela casella, federico guerra, antonio dello russo, b-po04-127 efficacy and safety of catheter ablation for ventricular tachycardia using ablation index: the idea vt study.27 jul 2021; heart rhythm, volume 18, issue 8, supplement, 2021, pages s330-s331, issn 1547-5271, https://doi.Org/10.1016/j.Hrthm.2021.06.821.Objective: catheter ablation (ca) is an important option for patients with ventricular tachycardia (vt) and/or electrical storm (es).The role of ablation index (ai), a lesion quality marker incorporating contact force, power, and time is yet to be defined in the field of vt/es ca.The purpose of this abstract is to assess safety and efficacy of ca for vt and/or es using catheters featuring the ai module.Methods/study data: the authors conducted a multicentric prospective observational study, the idea vt study, enrolling patients undergoing ca for vt and/or es in four high-volume italian referral centers.The authors studied 75 patients in whom ca was performed under the guidance of the carto electroanatomical mapping system, using the thermocool smarttouch ablation catheter featuring the ai module.For each procedure, mean, minimum, and maximum ai values were recorded.The patient¿s the median age was 67 and 66 (88%) were male.After a median follow-up of 284 days, survival free from vt recurrences measured 88%; three patients (4%) experienced serious adverse events (1 complete atrioventricular block, 1 aortic valve cusp perforation, 1 phrenic nerve palsy).The authors concluded that ca of vt using catheters incorporating the ai module and reaching a mean ai of 452 resulted in favorable mid-term efficacy outcomes, while avoiding serious complications in 96% of the study population.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter using ai module.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: n/a.Adverse event(s) and provided interventions: 1 complete av block- treatment unspecified.1 aortic valve cusp perforation- treatment unspecified.1 phrenic nerve palsy, treatment unspecified.

Manufacturer Narrative

Manufacturer's ref.(b)(4).This complaint is from a literature source.The following literature cite has been reviewed: paolo compagnucci, giovanni volpato, umberto falanga, giulia santarelli, michela colonnelli, alessio gasperetti, giulia stronati, laura cipolletta, fabrizio guarracini, giovanni carreras, corrado carbucicchio, claudio tondo, michela casella, federico guerra, antonio dello russo, b-po04-127 efficacy and safety of catheter ablation for ventricular tachycardia using ablation index: the idea vt study.27 jul 2021; heart rhythm, volume 18, issue 8, supplement, 2021, pages s330-s331, issn 1547-5271, https://doi.Org/10.1016/j.Hrthm.2021.06.821.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 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: 12580632
• MDR Text Key: 280508675
• Report Number: 2029046-2021-01685
• 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: company representative,litera
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF 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: CARTO 3 ELECTRONIC MAPPING SYSTEM
• Patient Outcome(s): Life Threatening; Required Intervention