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 Dyspnea (1816); Cardiac Perforation (2513); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the 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.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: michaelis a, dähnert i, riede ft, paetsch i, jahnke c, paech c.A case report: amplatzer occluder device closure of an iatrogenic ventricular septal defect following radiofrequency ablation.Eur heart j case rep.2021 apr 12;5(4):ytab094.Doi: 10.1093/ehjcr/ytab094.Pmid: 34124545; pmcid: pmc8188866.Objective: the purpose of this article was to review a case study of a patient with ventricular septal defect flowing a rfa to treat pvcs.Methods/study data: (b)(6) patient received a rfa to treat new-onset heart failure secondary to pvcs and atrial fibrillation as well as moderately impaired lv ejection fraction.Electroanatomical mapping identified clinical pvc origin in the basal right ventricular septum.Both sided endocardial ablation of the interventricular septum was performed with an irrigated tip 4mm catheter (smarttouch sf f curve- bwi).The intraprocedural course appeared uneventful; no steam pops have been observed.A routine follow-up transthoracic echocardiography 3 days later demonstrated normal systolic lv function and the absence of pericardial effusion.One-week post-ablation, chest pain and progressive dyspnea occurred, and a 4/6 systolic cardiac murmur was noted.Transthoracic echocardiography (tte) detected a vsd, (diameter 10mm).Hence, iatrogenic, rfa-related myocardial injury was considered the most likely cause of vsd.Cmr-cine imaging depicted a 10mm vsd of the basal anteroseptal segment with significant left-to-right shunt; left and right ventricular dimensions and function were normal.Cmr imaging demonstrated border-zone edema of the ventricular defect.Patient was referred for a percutaneous device closure procedure.Upon entering the site, laevocardiography identified two vsds: one mid-ventricular defect (diameter 10mm) and an additional, smaller muscular defect (4mm), and significant left-to right shunt was demonstrated.After the transseptal puncture, an amplatzer muscular vsd occlude (14mm) was deployed in the mid-ventricular defect and a second one (12mm) in the muscular defect.The author notes that the more apical vsd cannot be explained by analyzing the carto- map.Therefore, it can only be assumed that the second more apical vsd could be pre-existing.No intra- or post-procedural complications were recorded.The patient was discharged 6 days after successful vsd closure in a good clinical condition.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch sf f curve- bwi other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: imaging and/or videosavailable pp 3, 4, and 5 dyspnea, heart murmur, and additional surgical repair to treat vsd and minor muscular injury secondary to rf ablation procedure.".

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12389382
• MDR Text Key: 268901043
• Report Number: 2029046-2021-01437
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/27/2021

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: No Information
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 08/30/2021
• 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): Other
• Patient Age: 78 YR