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

Catalog Number D139505

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During application (mid procedure), pressure increase above 100g.After application, the pressure returned to the initial state.No consequences for the patient reported.The physician replaced the product with a like device.The procedure continued.No patient consequences were reported.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The force feature was tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device batch number 31167716l, and no internal actions were identified.The reddish material inside the pebax could be related to the force issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during procedure; however, this cannot be conclusively determined.; however, this cannot be conclusively determined.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: 19002009
• MDR Text Key: 339216885
• Report Number: 2029046-2024-01059
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 31167716L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2023
• 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