MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Pericardial Effusion (3271); Pericarditis (4448)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed lam a, küffer t, hunziker l, nozica n, asatryan b, franzeck f, madaffari a, haeberlin a, mühl a, servatius h, seiler j, noti f, baldinger sh, tanner h, windecker s, reichlin t, roten l.Efficacy and safety of ethanol infusion into the vein of marshall for mitral isthmus ablation.J cardiovasc electrophysiol.2021 jun;32(6):1610-1619.Doi: 10.1111/jce.15064.Epub 2021 may 5.Pmid: 33928711.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.The literature article's electronic file size is too large to be attached and submitted.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed lam a, küffer t, hunziker l, nozica n, asatryan b, franzeck f, madaffari a, haeberlin a, mühl a, servatius h, seiler j, noti f, baldinger sh, tanner h, windecker s, reichlin t, roten l.Efficacy and safety of ethanol infusion into the vein of marshall for mitral isthmus ablation.J cardiovasc electrophysiol.2021 jun;32(6):1610-1619.Doi: 10.1111/jce.15064.Epub 2021 may 5.Pmid: 33928711.Objective and methods: chemical ablation by retrograde infusion of ethanol into the vein of marshall (vom-ei) can facilitate the achievement of mitral isthmus block.This study sought to describe the efficacy and safety of this technique.Twenty-two consecutive patients (14 males, median age 71 years) with attempted vom-ei for mitral isthmus ablation between june 2019 and august 2020 were included in the study.Vom-ei was successfully performed with a median of 4ml of 96% ethanol in 19 patients (86%) and the mitral isthmus was successfully blocked in all (100%).The authors concluded that vom-ei is feasible, safe, and effective to achieve acute mitral isthmus block.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool stsf irrigated tip ablation catheter other biosense webster devices that were also used in this study: carto 3 and pentaray mapping catheter non-biosense webster devices that were also used in this study: all associated with the lapwi procedure.Agilis nxt (abbott) 8.5 fr steerable cannulation catheter.Unk left internal mammary artery (lima) guide catheter.Emerge 1.5¿2.5mm x 8 mm percutaneous coronary angioplasty balloon (bostonscientific) sion blue (asahi intecc usa) preloaded coronary guidewire.Adverse event(s) and provided interventions: 3 cases of pericardial effusion requiring no treatment.1 case of mild pericarditis requiring no treatment.1 case of new onset symptomatic sinus arrest requiring implantation of an icd 24 hours.After ablation- captured as bradycardia.2 cases of uneventful vom dissection during cannulation with a competitor canulation.Catheter ¿ not associated with a bwi product.Treated with successful recannulation and without further complications.".

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL SF
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12587157
• MDR Text Key: 275184850
• Report Number: 2029046-2021-01686
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2021

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_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/06/2021
• 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): Required Intervention