MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.

Event Description

This complaint is from a literature source.The following complication was reported in this publication: a (b)(6) man with symptomatic paroxysmal af and no structural abnormalities on echocardiogram was referred for radio-frequency (rf) catheter ablation.By using carto3 navigating system (biosense webster inc.) and a 3.5mm irrigated tip catheter (navistarthermocool; biosense webster inc.), circumferential antral isolation of the pulmonary veins was performed, with rf energy delivery (40 w, 20 s pulses; 20 w to target the posterior wall of the left atrium) being limited by luminal esophageal temperature (let) monitoring.The procedure, performed with the patient under general anesthesia was uneventful, with no significant rise in esophageal temperature.After the procedure, the patient remained asymptomatic and with normal physical examination.However, the routine endoscopy performed at day 5 showed a deep esophageal ulcer.Placement of a gastric probe for enteral nutrition; sublingual atropine eyedrops to avoid saliva production, proton pump inhibitors in double standard dose¿80 mg per day, and sucralfate oral suspension three times a day were required as intervention.A custom enpt drain system was also used as treatment.At day 23, only a shallow residual lesion covered with fibrin noticeable at control endoscopy was observed.The patient was discharged, and a final endoscopy at day 30 demonstrated no residual lesions.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 navistarthermocool; biosense webster inc.Other biosense webster devices that were also used in this study: carto 3 non-biosense webster devices that were also used in this study: none publication details title: a novel treatment for esophageal lesions following atrial fibrillation ablation objective: this study presents a novel technique for the treatment of a deep esophageal ulcer after ablation of paroxysmal atrial fibrillation (af).Methods: a 43 year old man with symptomatic paroxysmal af and no structural abnormalities on echocardiogram was referred for radio-frequency (rf) catheter ablation.By using carto3 navigating system (biosense webster inc.) and a 3.5 mm irrigated tip catheter (navistarthermocool; biosense webster inc.), circumferential antral isolationof the pulmonary veins was performed, with rf energy delivery(40 w, 20 s pulses; 20 w to target the posterior wall of the left atrium) being limited by luminal esophageal temperature (let) monitoring.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• 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: 11616172
• MDR Text Key: 243907105
• Report Number: 2029046-2021-00509
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR