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 Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.After conducting a visual analysis, a hole was discovered in the pebax material, exposing the internal components of the device.Additionally, dry blood was observed inside the device.The device was connected to ngen and carto 3 systems and the device was recognized correctly; the force values and the vector were observed within specifications.No force issues were observed.However, considering the observed condition, it is possible that the hole in the pebax could have contributed to the reported event.The reported customer issue was confirmed, and the product failure was found to be multifactorial.The pebax material was identified as one of the factors.Initial assessment indicates that handling may be a potential cause, despite the existence of control inspection points aimed at preventing such issues.A manufacturing record evaluation was performed for the finished device number 30930189l, 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).

Event Description

It was reported that a patient underwent a left ventricular ablation 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 contact force suddenly increased mid-ablation, left ventricular ablation in particular.The issue was resolved by replacing the qdot micro catheter to another new one.The procedure was completed without patient's consequence.The force issue is not mdr-reportable.The hole in the pebax is mdr-reportable.

• 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: 17685289
• MDR Text Key: 322669655
• Report Number: 2029046-2023-01990
• 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: 09/05/2023

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: 30930189L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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