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 01/15/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and something felt like it was stuck during flushing.There was no problem to first ablation from qdot micro catheter connection.Right after first ablation was started, temperature reading was over 50 degrees celsius and significant titration was applied.Output became low and part of the bullseye display became red.The ablation never continued beyond the cut-off value.After the first ablation, the catheter was removed.The tip of the catheter was wiped off and flushing was performed.There was no blood or char found on the tip, but dripped as if something was stuck during flushing.Dripped from the tip of the catheter for a while even after flushing was stopped.It was improved by replacing the catheter with a new one.The procedure was completed without patient consequence.The high temperature issue is not mdr reportable.The irrigation issue is considered mdr reportable.

Manufacturer Narrative

A picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 a cardiac ablation procedure with a qdot micro¿ catheter and something felt like it was stuck during flushing.There was no problem to first ablation from qdot micro catheter connection.Right after first ablation was started, temperature reading was over 50 degrees celsius and significant titration was applied.Output became low and part of the bullseye display became red.The ablation never continued beyond the cut-off value.After the first ablation, the catheter was removed.The tip of the catheter was wiped off and flushing was performed.There was no blood or char found on the tip, but dripped as if something was stuck during flushing.Dripped from the tip of the catheter for a while even after flushing was stopped.It was improved by replacing the catheter with a new one.The procedure was completed without patient consequence.The high temperature issue is not mdr reportable.The irrigation issue is considered mdr reportable.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 following bwi procedures.Visual analysis of the returned sample revealed no damage or anomalies on the device.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.The issues 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.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Biosense webster manufacturer's reference number pc-001522816 has two reports: (1) mfr # 2029046-2024-00409 for product code d139505 (qdot micro¿ catheter) (2) mfr # 2029046-2024-00613 for product code (b)(4) (ngen rf generator, japan).

Manufacturer Narrative

On 30-jan-2024, additional information was received regarding the generator.It was reported that the generator settings have not been changed for 6 months since installation.This indicated that the generator was set on automatic mode.On 13-feb-2024, it was reported that servicing was not needed for the pump at this time.Additionally, the manufactured and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00409 for product code d139505 (qdot micro¿ catheter).(2) mfr # 2029046-2024-00613 for product code ip-01973514 (ngen rf generator, japan).

• 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: 18656244
• MDR Text Key: 334744216
• Report Number: 2029046-2024-00409
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

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: 31182153L
• 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: 02/06/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 02/26/2024
• Supplement Dates FDA Received: 02/23/2024; 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NGEN PUMP, JAPAN CONFIGURATION.; NGEN RF GENERATOR, JAPAN.