MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO, BI, TC, D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139505

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

Patient Problems Unspecified Infection (1930); Laceration(s) of Esophagus (2398)

Event Date 12/19/2022

Event Type  Death  

Event Description

During a clinical trial, sponsored by biosense webster inc., was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter under general anesthesia.The patient experienced bloody, necrotic esophageal stenosis requiring surgical intervention.The patient ultimately passed away.On (b)(6) 2022, patient experienced bloody, necrotic esophageal stenosis categorized as severe and serious as defined by prolonged hospitalization from (b)(6) 2022 the patient ultimately passed away.Relationship to study device is not related and relationship to primary study procedure is causal relationship to the index procedure.The adverse event is unexpected/unanticipated.The outcome is fatal.Intervention was surgery, stenting.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30874958l number, and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This report is being submitted late due to a retrospective review of complaints for the qdot micro products.Biosense webster¿s investigation determined that upon approval of qdot in the united states on november 23, 2022, the electronic complaints system was not updated and therefore medical device reports were not submitted in a timely manner.Through biosense webster¿s investigation it was determined that this was an isolated case.An internal action was opened to address this issue.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

On 25-mar-2024, an update was made to the clinical database.It was noted that there was no stenting done.The surgical intervention was removed from the treatment section.Therefore, the h 6.Health effect - impact code of ¿surgical intervention (f19)¿ was removed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT MICRO, BI, TC, D-F
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17620292
• MDR Text Key: 321916816
• Report Number: 2029046-2023-01883
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 30874958L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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
• Treatment: NGEN RF GENERATOR; OCTA,LNG,48P,2-5-2-5-2,D-CURVE; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Required Intervention; Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 26 KG