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

Catalog Number D139505

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and after the catheter had been used for some time during the procedure, the physician went to flush the catheter and char got stuck in the syringe.The physician ended up removing the catheter from the body and did not replace the catheter since they were at the end of the procedure.There were no error messages on the equipment.The patient was properly anticoagulated.According to the physician, the amount of char did not present a patient risk.No patient consequences were reported.

Manufacturer Narrative

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

Manufacturer Narrative

On 19-feb-2024, bwi received additional information indicating that the patient had no suffered from any neurological symptoms post procedure.On 14-mar-2024, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 18-mar-2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and after the catheter had been used for some time during the procedure, the physician went to flush the catheter and char got stuck in the syringe.The physician ended up removing the catheter from the body and did not replace the catheter since they were at the end of the procedure.There were no error messages on the equipment.The patient was properly anticoagulated.According to the physician, the amount of char did not present a patient risk.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, temperature, impedance and patency test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed no damage or anomalies on the device.No char, thrombus or clot residues were observed during the inspection.The temperature and impedance test was performed, and no issues were observed.A patency test was performed, and the device was flushing correctly.No issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31210183l and no internal actions related to the complaint was found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Monitoring the temperature from the electrode during the application of rf (radiofrequency) current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.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: 18800835
• MDR Text Key: 336517990
• Report Number: 2029046-2024-00667
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31210183L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 02/19/2024; 03/18/2024
• Supplement Dates FDA Received: 03/14/2024; 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• 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: CARTO 3 SYSTEM WITH VISITAG.; NGEN GENERATOR.; UNSPECIFIED PUMP.