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 Problem Paralysis (1997)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: tohoku s, bordignon s, chen s, bologna f, urbanek l, operhalski f, chun kj, schmidt b.Validation of lesion durability following pulmonary vein isolation using the new third-generation laser balloon catheter in patients with recurrent atrial fibrillation.J cardiol.2021 nov;78(5):388-396.Doi: 10.1016/j.Jjcc.2021.07.001.Epub 2021 jul 29.Pmid: 34332839.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 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.Manufacturer¿s reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: tohoku s, bordignon s, chen s, bologna f, urbanek l, operhalski f, chun kj, schmidt b.Validation of lesion durability following pulmonary vein isolation using the new third-generation laser balloon catheter in patients with recurrent atrial fibrillation.J cardiol.2021 nov;78(5):388-396.Doi: 10.1016/j.Jjcc.2021.07.001.Epub 2021 jul 29.Pmid: 34332839.Objective: the second- and third-generation endoscopic ablation systems (eas2 and eas3) have been launched in recent years.We aimed to assess the lesion durability as well as gap localization using the multigenerational novel technologies in patients with recurrent atrial fibrillation (af).Methods/study data: consecutive 225 patients who underwent second ablation for recurrent af following the initial pulmonary vein isolation (pvi) with eas2 or eas3 between may 2017 and march 2021were retrospectively investigated.The persistent durability of pvi, gap localization at the second procedure, and procedural/anatomical features of durable pvi were analyzed.Among 225 patients treated with eas3 (n = 125) and eas2 (n = 100), 34 patients (eas3: 13 patients, 50 pvs, eas2: 21 patients, 82 pvs) underwent a second procedure because of recurrent af mean 11.9 ± 9.3 months after the initial procedure.Persistent isolation of all four pvs was recorded in 6 (46.2%) patients in eas3 group and 4 (19.1%) patients in eas2 group (p = 0.130).Ninety-one out of 132 (68.9%) pvs were persistently isolated with a higher rate in eas3 group (82.0% vs.Eas2 group: 61.0%, p = 0.0113).All repeat procedures were performed using 3d mapping system (carto3) with a double transseptal puncture.Selective p angiography was thereafter performed to exclude pv stenosis.In case of af, a sinus rhythm was restored by external electrical cardioversion.A spiral mapping catheter (lasso 15 mm) was used to evaluate persistency of electrical conduction block of pvs and location of conduction gap.In case of resumed la to pv conduction, gap localization was identified with combination to intra cardiac electro- gram on the spiral mapping catheter and detailed activation map- ping using a 3.5 mm-irrigated tip catheter (thermocool smarttouch sf).There was one complication noted in this study: a single phrenic nerve paralysis was observed in eas3 (1/13 7.7%).The patient had recovered at the outpatient visit 3 months later.The authors concluded that the technical innovation resulted in a higher lesion durability in eas3-guided pvi in patients with recurrent af.The most common gap location was found at rspv in successor eass.Ablation without reduced energy was a predictor of durable pvi in successor eass.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf sensing ablation catheter ablation catheter.Other biosense webster devices that were also used in this study: carto 3d system.Lasso 15 mm circular mapping catheter.Non-biosense webster devices that were also used in this study: na.Adverse event(s) and provided interventions: 1 phrenic nerve palsy.No treatment specified.Patient had full recovery at 3 months follow-up.

• 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
• MDR Report Key: 12607515
• MDR Text Key: 280698690
• Report Number: 2029046-2021-01729
• 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,foreig
• Type of Report: Initial
• Report Date: 09/18/2021

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
• Initial Date Manufacturer Received: 09/18/2021
• Initial Date FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3D SYSTEM; LASSO 15 MM CIRCULAR MAPPING CATHETER
• Patient Outcome(s): Life Threatening