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 Signal Artifact/Noise (1036); Insufficient Cooling (1130); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unspecified cardiac ablation procedure with a qdot-micro, uni-directional, f curve, c3, split handle and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, multiple errors occurred.The errors were the following: temp slope error, force jumping up when ablating, map 1 and 2 signal diminishing, noise on the recording system and carto, and high temperatures when ablating (37 degrees before ablation increasing to 47 degrees even when power was titrated down to 3 watts).The qdot dongle was rebooted but the issues persisted.The qdot dongle was changed and the issues didn't resolve.The cable was changed and the ngen was rebooted, but neither resolved the issues.The catheter was removed to test the irrigation and the irrigation was appropriate.No visible char was noted.However, upon catheter removal the blood was noted inside the tip of the catheter around the force spring.The catheter was replaced and the procedure continued.The overall delay was approximately 10 minutes.The procedure continued and no patient consequences were reported.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, reddish material was observed inside the pebax; however no external damages were observed on the pebax.The reddish material observed inside the pebax could be related to the force and temperature issues reported by the customer; however, this cannot be conclusively determined.Additionally, the product was returned for evaluation.Biosense webster (bwi) conducted a visual inspection, screening, temperature, impedance, electrical, and patency flow test of the returned device.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Temperature, impedance, and patency testing were performed per bwi procedures.The catheter temperature, impedance, and patency were working correctly and within specifications.No malfunction was observed.Electrical testing was performed.The device was working correctly and within specifications.No malfunctions were observed.The force, high temperature, and electrical issues described were unable to be duplicated during the product investigation however, the blood inside the pebax area found could be related to the reported issues.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.To minimize the temperature issue, the following guidelines should be followed.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If the temperature increases to 40°c during rf (radiofrequency) energy delivery, power delivery should be interrupted.To minimize ecg (electrocardiogram) noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.A manufacturing record evaluation was performed for the finished device 31043547l number, and no internal actions related to the reported complaint condition were identified.As part of bwi¿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, 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: 18314223
• MDR Text Key: 330942262
• Report Number: 2029046-2023-02923
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

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: D139402
• Device Lot Number: 31043547L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• 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: AGILIS SHEATH 8.5; CARTO 3 SYSTEM; NGEN GENERATOR