MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's reference number: (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 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 complications were reported in this publication: it was reported that 3 patients underwent pulmonary vein isolation for atrial fibrillation (af) ablation and suffered asymptomatic endoscopic small erosion/erythema esophageal lesions.Three patients had endoscopy detected asymptomatic small esophageal lesions (5-15 mm, erosion/erythema, suspected as rf thermal lesions); they were carefully followed up, ppi therapy was continued for 4 weeks, and no clinical sequelae were observed.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: lasso, carto 3 non-biosense webster devices that were also used in this study: sl1, 8.5f, nonsteerable sheath, circa probe (circa scientific).Publication details: title: catheter ablation of atrial fibrillation using ablation index-guided high-power technique: frankfurt ai high-power 15-month follow-up.Objective: radiofrequency (rf) high-power ablation appears to be a novel concept in treating atrial fibrillation (af).The ablation-index (ai) has been linked with the durability of pulmonary vein isolation (pvi).To report the midterm clinical results of a new ablation strategy using ai-guided high-power (50 w) ablation (ai-hp).Methods: symptomatic af patients were included and underwent wide-area circumferential pvi.Contact-force catheters were used, rf power was set to 50 w targeting ai values (550/400 for anterior/posterior) and interlesion distance 6 mm.Luminal esophageal temperature (let) was monitored during the procedure; patients with let =39°c underwent post-ablation esophageal-endoscopy.Seventy-two-hour-holter ecgs were scheduled during follow-up.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 11530146
• MDR Text Key: 242461991
• Report Number: 2029046-2021-00383
• Device Sequence Number: 1
• Product Code: LPB
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• 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
• Patient Age: 68 YR