MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: pc (b)(4).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.Biosense webster manufacturer's report number: 2029046-2020-01394.Is related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent catheter ablation of atrial fibrillation and suffered right phrenic nerve paralysis.Intervention was not reported.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is thermocool smarttouch sf.Other biosense webster devices that were also used in this study: biosense array intra-cardiac ultrasound catheter intracardiac echocardi-ography, carto 3, pentaray nav, martablate rfgenerator non-biosense webster devices that were also used in this study: acunav intracardiac echocardi-ography catheter, siemens intracardiac echocardi-ography catheter, boston scientific dynamic xt, abbott gilisnxt, abbott sl, publication details title: impact of high-power short-duration radiofrequency ablation on long-term lesion durability for atrial fibrillation ablation objective: the goal of this study was to compare lesion durability between high-power short-duration (hp-sd) andmoderate-power moderate-duration (mp-md) ablation strategies.Methods: patients with atrialfibrillation (n¼112) underwent pvi using hp-sd ablation (45 to 50 w, 8 to 15 s) with contact force-sensing open irrigated catheter.Cavotricuspid isthmus, mitral annular, and roof lines were permitted.Acontrol group (n¼112) underwent ablation using mp-md ablation (20 to 40 w, 20 to 30 s) with similar technology.Chronic pv reconnection was examined in patients who required a redo procedure (hp-sd ablation, n¼18; mp-mdablation, n¼23).

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 10628194
• MDR Text Key: 209973273
• Report Number: 2029046-2020-01395
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• 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: 09/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR