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

Catalog Number D139402

Device Problem Insufficient Information (3190)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

The b section event date was listed as "(b)(6) 2023".However, the actual event date could not be confirmed.Therefore, the event date was listed as the manufacture date, as the event could have only occurred after manufacture.The product investigation was completed.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection, screening test of the returned device were performed following bwi procedures.Visual analysis revealed a cracked pebax in the tip area.The root cause of the damage could be related to improper handling; however, this cannot be conclusively determined.There are control inspection points to avoid these issues.A screening test was performed, and no temperature was displayed due to an open circuit in the tip area.However, the impedance was displayed properly.Based on the information currently available, two product issues were identified during the investigation of the sample received.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device number 31047911l, 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.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

A qdot micro¿ catheter was received by the biosense webster inc.(bwi) product analysis lab on 19-jul-2023, with no accompanying information and the device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to bwi.However, visual analysis conducted on 14-sep-2023 revealed a cracked pebax in the tip area.As such, this is now considered mdr reportable.The awareness date is 14-sep-2023.

• Brand Name: QDOT MICRO, UNI, TC, F
• 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: 17927575
• MDR Text Key: 326274374
• Report Number: 2029046-2023-02310
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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: 31047911L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1