MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139402

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/24/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure that included a qdot-micro, uni-directional, f curve, c3, split handle.The patient experienced a cardiac tamponade that required pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported by the biosense webster inc.(bwi) representative that a cardiac tamponade occurred during an atrial fibrillation procedure, mid-procedure and during ablation.A pericardial effusion was discovered and confirmed while looking on intracardiac echocardiography (ice).There were no indications of any issues.There were no visible signs on the patient.There were no high-force readings and no steam pops during the procedure.The procedure was aborted.A pericardiocentesis was performed and that 1 to 1.5 liters of fluid was removed.They also put back an unknown amount of fluid into the patient.The bwi representative reported that they were currently cracking the patient's chest in surgery and sewing the heart shut.The patient was reported to be in stable condition at the time of the call.Service was declined.Analysis of the ablation catheter was requested.The physician¿s opinion on the cause of this adverse event was that the tip of the ablation catheter punctured through the cardiac tissue near the left atrial appendage.There were nearly 2 seconds of 40 grams force that was not indicated/read on carto despite force settings programmed to default and to update every 1000 msec.Procedure related incident.Patient outcome is improved.Extended hospital stay was necessary for recovery from surgery.Other relevant history includes atrial fibrillation, no previous ablation.Transseptal puncture was performed with versacross baylis with fixed baylis sheath.Unable to obtain lot information for sheath and needle.A qdot catheter was used.Flow settings: high flow max 15ml//min, high flow min 4ml/min, low flow 2ml/min, pre ablation flush 2 seconds, post ablation flush 0 seconds.Max low flow temp 45 degrees celsius.The correct catheter settings were selected on the generator and the pump switched from "low" to "high" flow during ablation.No error messages observed on bwi equipment during the procedure.Force visualization features used were graph, dashboard, vector, visitag and catheter view toolbar were all in use during the entirety of the procedure.The parameters for stability used were stability 3mm 5 seconds, 2mm tag size (no fot).Projected grid displayed.Additional filter used with visitag was respiratory gaiting applied.Visitag color option was used, median temp custom 35-45 degrees.Grid color by total time.

Manufacturer Narrative

The product was returned to biosense webster (bwi) for evaluation.A visual inspection, screening test and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The force features were tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The other 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 31055856l and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The root cause of the adverse event remains unknown.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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

On 05-sep-2023, mdr report mw5144795 was received from the fda and after review, it was concluded that it is the same event as manufacturer report number 2029046-2023-01808.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, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE
• 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: 17579770
• MDR Text Key: 321514450
• Report Number: 2029046-2023-01808
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139402
• Device Lot Number: 31055856L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FIXED BAYLIS SHEATH; NGEN CONSOLE; VERSACROSS BAYLIS NEEDLE
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male