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

Catalog Number D139505

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an isolated supraventricular tachycardia procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified a damage/separation at the tip/shaft transition with exposed components.During the procedure, some ablation passes had been completed and a high force was displayed and the catheter image was lost on the carto® 3 system.A catheter sensor error (error#unknown) was also displayed on the carto® 3 system and there was a red light indicator on the qdot box.The medical team disconnected and reconnected the cable and the qdot box but the issue persisted.The cable was replaced but the issue persisted.The catheter was replaced and the issue was resolved.The case continued.No patient consequences were reported.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional tests of the returned device were following bwi procedures.Visual analysis revealed a damage/separation at the tip/shaft transition with exposed components.During the analysis adhesive was observed on the transition area, due this condition, the issue could be related to excessive force during manipulation of the device; however, this cannot be conclusively determined.The device was connected to the carto 3 system; however, error 105 was displayed on the screen due to an open circuit on the tip area.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the manufacturing process to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 31187972l number, and no internal actions related to the reported complaint condition were identified.The error 105 could be related to the issues reported therefore, the customer complaint was confirmed.The instructions for use contain (ifu) the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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¿ 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: 19000834
• MDR Text Key: 339212830
• Report Number: 2029046-2024-01055
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 31187972L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• 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: CARTO 3 SYSTEM; NGEN GENERATOR