MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Nerve Damage (1979); Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (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

Event description: this complaint is from a literature source.Literature article entitled "classification of left atrial diseased tissue burden determined by automated voltage analysis predicts outcomes after ablation for atrial fibrillation" written by szilvia herczeg, john j.Keaney, edward keelan, claire howard, katie walsh, laszlo geller, gabor szeplaki, and joseph galvin published by hindawi published 2021 jun 22;2021:5511267.Doi: 10.1155/2021/5511267.Pmid: 34257744 was reviewed.Model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch and smarttouch sf ablation catheters other biosense products utilized in study: lasso catheter (mapping), carto 3d eam system (mapping) with confidense module non-biosense products utilized in study: agilis long sheath (abbott).Exact quantities of involved products cannot be accurately determined as the article does not specify which specific ablation catheters are associated with each adverse event.The following adverse event(s) were reported in this publication and noted to be unrelated to mapping or the vha (voltage histogram analysis tool).Qty 3 of pericardial effusion requiring pericardial drainage.Qty 1 of severe pericarditis (article does not discuss intervention).Qty 1 of right phrenic nerve palsy (article does not discuss intervention)).Objective: the article's purpose is to describe and propose a new classification system to assess the diseased la tissue burden, based on the automated vha tool (dublin classification).We have also investigated the efficacy of the dublin classification in predicting recurrent af in patients who underwent pulmonary vein isolation (pvi).Methods: patient data: 109 dominantly male (76%) patients were included with a median age of 62 [55-70] years (table 2).Almost one-third of the patient population had persistent atrial fibrillation at the time of enrolment.Hypertension (36%), vascular disease (15%), and underlying heart disease (15%) were the most frequent comorbidities.7% of the patients had left ventricular ejection fraction (lvef) < 50%.

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 12372405
• MDR Text Key: 268479409
• Report Number: 2029046-2021-01399
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P030031/S053
• 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: 08/16/2021

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: 08/16/2021
• Initial Date FDA Received: 08/26/2021
• 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