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

Catalog Number D139505

Device Problems Coagulation in Device or Device Ingredient (1096); Insufficient Cooling (1130)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro catheter and a coagulum issue occurred.When the ablator was removed from the body, it was observed that there was coagulum on the tip of the catheter.The physician wiped it off, flushed the catheter and it seemed to be irrigating appropriately.The catheter was reinserted into the body and when the physician would come on ablation, a temperature slope too high error displayed on the ngen monitor and ablation was stopped.The physician removed the catheter from the body and more coagulum was observed on the tip of the ablation catheter.The catheter was replaced and the issue resolved.The case continued.There was no patient consequence reported.Additional information was received.The coagulum was located on the tip electrode.The ngen showed a "temperature slope too high" error message.The system stopped ablation when any of the cut off values were exceeded.The correct catheter settings were selected on the generator.Generator parameters were qmode; temp cutoff 47; power cutoff 40w.Noted was power 40w; impedance na; temperature starting low 30 and rose upon ablation on.The duration of ablation used was not greater than 60 seconds, just a couple of seconds maximum.The irrigation rate used was not outside of those prescribed.The average contact force was not greater than 25 grams.The pump was switching from ¿low¿ to ¿high¿ flow during the ablation.Heparinized normal saline was used as the irrigation fluid, no other used.The patient was anticoagulated.Act/300 was maintained throughout the case.Lesions not long enough for visitag to appear.The physician did not consider that the coagulum was excessive (based on their clinical experience).The physician did not consider the amount of coagulum observed caused a potential risk to this patient.The temperature slope too high error was assessed as non mdr reportable.Since the generator stopped delivering radio frequency (rf), 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 coagulum issue was assessed as mdr reportable.

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: pc-(b)(4).

Manufacturer Narrative

The investigation was completed on 03-apr-2024.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31224260l and no internal action related to the complaint was found during the review.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
• 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: 18947298
• MDR Text Key: 338552258
• Report Number: 2029046-2024-00964
• Device Sequence Number: 1
• Product Code: OAE
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 31224260L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2023
• 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 PUMP.; UNK_NGEN RF GENERATOR.