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

Catalog Number D139402

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, screening and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed a hole on pebax's surface with reddish material inside it.The magnetic and force feature were tested and no errors were observed, the device was visualized and recognized correctly.The force values and the vector were observed within specifications.No force issues was observed.Deflection testing was performed, and the deflection mechanism failed specifications due to the puller wire was found broken inside the handle.A manufacturing record evaluation was performed for the finished device 31177420l number, and no internal action related to the complaint was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The reddish material inside the pebax's could be related to the force issue reported by the customer.The root cause of the pebax's damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.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).

Event Description

It was reported a patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure when the catheter was inserted into the patient, the force reading was displayed on the carto 3 system as hi.The medical team was unable to zero the catheter.They zeroed the catheter multiple times but the issue persisted.Additionally, the catheter stopped deflecting mid-procedure.When the catheter was replaced, the issue was resolved.The procedure continued.No patient consequences were reported.

• 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: 18970115
• MDR Text Key: 338876404
• Report Number: 2029046-2024-01008
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 31177420L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2023
• 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: CARTO 3 SYSTEM; NGEN GENERATOR; NGEN PUMP; QDOT MICRO CATHETER