MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139505

Device Problems Insufficient Cooling (1130); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and post-procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, the first ablation stopped with "temperature slope too high".The medical team checked the screen recordings, both temperatures and forces were rising rapidly but there was no error.Flush was conducted and cable was replaced but the issue continued.The issue was resolved by replacing qdot micro catheter to another new one.The procedure was completed without any further problems.No patient consequences were reported.Additional information: temperature cut-off value: 50.Approximate temperature at the time of failure: 41.High-frequency generator serial: (b)(6).Type of temperature anomaly: temperature slope too high.The force issue isn't mdr-reportable.High temperature isn't mdr-reportable.Hole in the pebax is mdr-reportable.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, temperature, impedance, and screening tests of the returned device were performed following bwi procedures.Visual analysis: reddish material was observed inside the pebax material, no other anomalies were detected.A temperature and impedance test was performed, the device passed the test and showed no temperature or impedance issues.A screening test was performed and the device was recognized correctly; however, inaccurate force values were displayed due to an internal printed circuit board (pcb) issue.Microscopic analysis: a hole was found in the pebax material, exposing internal components.The root cause of this damage could be related to handling, as there are control inspection points in place to prevent such issues.This issue could contribute to the reported force and temperature issues by the customer.The entire issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: t if force readings might be inaccurate or another catheter is in proximity: an alert message appears, force readings on the dashboard are displayed in gray, and the force graph is colored white.Resolve the issue according to the directions in the alert message to enable force measurement.You can also continue the study without force data.A manufacturing record evaluation was performed for the finished device number 30918775l, and no internal action was found during the review.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, BI-DIRECTIONAL, D-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: 17512936
• MDR Text Key: 320914393
• Report Number: 2029046-2023-01762
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• 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
• Report Date: 08/11/2023

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: D139505
• Device Lot Number: 30918775L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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: NGEN GENERATOR