MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139504

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation afib - paroxysmal ablation procedure with a qdot micro¿ catheter and the patient experienced pericardial effusion that required pericardiocentesis.After a difficult transseptal procedure, the physician ablated in the left atrium.The patient's blood pressure began to decrease during ablation.The physician believed the pericardial effusion was a "slow leak".The ablation procedure was stopped, and 550 ccs of fluid was removed and returned to the patient and the blood pressure stabilized.The physician's opinion on the cause of the adverse event was that it was procedure related.The patient fully recovered but required extended hospitalization in the icu.Transseptal puncture was performed.Ablation was performed prior to noting the effusion.No evidence of steam pop.No error messages were observed on the biosense webster equipment during the procedure.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation afib - paroxysmal ablation procedure with a qdot micro¿ catheter and the patient experienced pericardial effusion that required pericardiocentesis.After a difficult transseptal procedure, the physician ablated in the left atrium.The patient's blood pressure began to decrease during ablation.The physician believed the pericardial effusion was a "slow leak".The ablation procedure was stopped, and 550 ccs of fluid was removed and returned to the patient and the blood pressure stabilized.The physician's opinion on the cause of the adverse event was that it was procedure related.The patient fully recovered but required extended hospitalization in the icu.Transseptal puncture was performed.Ablation was performed prior to noting the effusion.No evidence of steam pop.No error messages were observed on the biosense webster equipment during the procedure.Device evaluation details: on 03-jan-2024, the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31177432l and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The physician's opinion on the cause of the adverse event was the procedure.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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¿ CATHETER
• 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: 18414897
• MDR Text Key: 331578158
• Report Number: 2029046-2023-03122
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: 10846835016741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139504
• Device Lot Number: 31177432L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• 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: BRK NEEDLE.; UNK_CARTO 3.; UNK_NGEN RF GENERATOR.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female