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 Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter and when pulling out the catheter to change sheaths, coagulation was observed under the pebax of the catheter tip.The catheter was in the right atrium.No ablation performed.The ngen pump was continuously running at 2ml/min.No error messages appeared.The catheter was changed, and the procedure was completed.There was no patient consequence.A vizigo small curve sheath was used during the procedure.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.This event was originally assessed as not mdr reportable.The device was returned for analysis and revealed reddish material inside the pebax and a hole in its surface.The hole in the pebax makes this event mdr reportable.

Manufacturer Narrative

The event date is unknown.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, reddish material was observed inside the pebax; however, there is no evidence of an external damage on the pebax.The customer complaint was confirmed based on the picture received.Additionally, the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed reddish material inside the pebax and a hole in its surface.The root cause of the damage on the pebax could not be conclusively determined, but it was concluded that it occurred outside the bwi manufacturing facilities and could be related to the failure described by the customer.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30946635l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This report is being submitted late due to a retrospective review of complaints for the qdot micro products.Biosense webster¿s investigation determined that upon approval of qdot in the united states on november 23, 2022, the electronic complaints system was not updated and therefore medical device reports were not submitted in a timely manner.Through biosense webster¿s investigation it was determined that this was an isolated case.An internal action was opened to address this issue.Manufacturer's ref.No: (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: 17623845
• MDR Text Key: 321951840
• Report Number: 2029046-2023-01895
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: 30946635L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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: UNK_NGEN PUMP