MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Myocardial Infarction (1969); Perforation of Vessels (2135); Cardiogenic Shock (2262)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: klaudel j, glaza m, kosmalska k, szolkiewicz m.Delayed presentation of left main coronary artery dissection due to catheter ablation in a patient with bicuspid aortic valve.Coincidence or manifestation of inherent vulnerability? j cardiol cases.2020 jul 28;22(6):269-272.Doi: 10.1016/j.Jccase.2020.07.004.Pmid: 33304418; pmcid: pmc7718513.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 no lot number was provided by the customer.The literature file is too large and therefore, unable to attach.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: klaudel j, glaza m, kosmalska k, szolkiewicz m.Delayed presentation of left main coronary artery dissection due to catheter ablation in a patient with bicuspid aortic valve.Coincidence or manifestation of inherent vulnerability? j cardiol cases.2020 jul 28;22(6):269-272.Doi: 10.1016/j.Jccase.2020.07.004.Pmid: 33304418; pmcid: pmc7718513.Objective/methods/study data: left main coronary artery (lmca) injury is an uncommon complication of catheter ablation.Due to the large myocardial area at risk, its presentation is usually acute with a dramatic course and life-threatening sequelae.Increased susceptibility to spontaneous coronary artery dissection has recently been implied in patients with bicuspid aortic valve (bav).We present the first case of iatrogenic coronary dissection in a bav patient, with an atypically delayed manifestation.The patient sustained ablation catheter-induced mechanical damage of lmca due to its inadvertent penetration during the attempts to cross the aortic valve.After three days of recurring chest pain, he was readmitted with anterior myocardial infarction and imminent cardiogenic shock, and underwent emergent coronary stenting.Literature review suggests that in bav inherent susceptibility to both spontaneous and iatrogenic coronary dissection may exist.Therefore, we advocate that in bav extreme caution should be exercised during electrophysiological procedures involving the coronary artery cannulation for tagging or pace mapping, or when the left ventricle is to be entered retrogradely, and likewise in percutaneous coronary interventions.Such patients may be doubly predisposed to iatrogenic injury; firstly, by more difficult catheter manipulation in the malformed aortic cusps, and secondly, by the underlying vulnerability of coronary ostia.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 7 french thermocool.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: it was reported from a literature source that a (b)(6) male patient suffered procedure related complications; myocardial infarction, cardiogenic shock, and vessel perforation requiring surgical intervention.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14014733
• MDR Text Key: 288611631
• Report Number: 2029046-2022-00725
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male