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

Catalog Number D139505

Device Problems Insufficient Cooling (1130); Obstruction of Flow (2423)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro¿ catheter and an irrigation issue while on use in the patient occurred.During the procedure with the patient on the table and the physician scrubbed in, diagnostic and therapeutic catheters were inserted into the heart.Cardiac atrial mapping had been completed with the mapping catheter.An ablation plan had been set and ablator was inserted into heart.Catheter was zeroed successfully and first ablation lesions were made.At this time, they noticed that the power was being cut off early due to a sharp increase in temperature.The pump appeared to be running normally.However, when they flushed the line, they realized that they were unable to flush the catheter.All connections checked.The line was separated and flushed in pieces and they found no blockages.They attempted to flush the catheter while it was disconnected from the line and realized no fluid could enter the lumen.It feels as though there was a block in the lumen of the catheter.No patient consequence.Procedure prolonged approximately 10 minutes.The temperature issue was assessed non mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The irrigation issue while on use in the patient was assessed as mdr reportable.

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.E1.Initial reporter phone:(b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).

Manufacturer Narrative

Additional details about this event were obtained under a duplicate bwi file.Additional event details indicated the tech identified high temperature cut off on the ngen.Physician attempted to flush the catheter and the irrigation would not work.They restarted the pump and ensured there was no char on the catheter tip blocking the pores.Irrigation would not flow through the catheter.Swapped the catheter and continued the procedure.The correct catheter settings were selected on the ngen rf generator but the pump was not switching from low to high during ablation.There were no errors.The high temperature was noticed on the ngen monitor.The patient was unaffected at the time.The following fields have been updated based on the new information obtained: b3.Date of event was updated from 15-jan-2024 to 21-sep-2023.D4.Lot was updated from 31167777l to 31043567l.D9.Date device returned to manufacturer was updated to 21-nov-2023.G3.Date received by manufacturer of initial report should be considered updated from 15-jan-2024 to 21-sep-2023.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation and the evaluation was completed.Visual inspection and functional tests of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device was connected to the ngen and it was noted that there was a partial irrigation.An ablation cycle was performed, and it was observed with high-temperature values.Patency test was performed and occluded holes were found.As such, a microscopic examination was performed, and it was noted that the holes were occluded with a reddish material.The source of the foreign material could not be determined; however, it was concluded that could have been done during the use of the device.The occluded holes are the potential cause of the high temperature values.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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 ref.# (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: 18673751
• MDR Text Key: 335218466
• Report Number: 2029046-2024-00436
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 31043567L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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: UNK MAPPING CATHETER; UNK PUMP