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

Catalog Number D139401

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

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a lack of adhesive on the anchorage section of tip.It was initially reported by the customer that in qmode plus, the force rised abnormally.Changing catheter solved the issue.There was no patient consequence.The customer¿s reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a lack of adhesive on the anchorage section of tip.This finding was reviewed and assessed as an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a product malfunction on (b)(6) 2023 and reassessed the event as reportable.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A screening test was performed, and the device was visualized and recognized correctly; however, during the testing, the catheter was deflected showing high force values and the negative force vector.Due to this a manufacturing investigation was performed and lack of adhesive on the anchorage section of tip was observed.An awareness session was performed to avoid this type of issues.A manufacturing record evaluation was performed, 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.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 ref.# (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: 18179443
• MDR Text Key: 328629200
• Report Number: 2029046-2023-02717
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: 10846835017045
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 11/20/2023

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: D139401
• Device Lot Number: 31033508L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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: UNK_NGEN RF GENERATOR.