MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number	D134301
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) cardiac ablation procedure which included the use of a lasso® nav eco variable catheter and the patient experienced atrial fibrillation (afib) treated with cardioversion.It was reported that when inserting the lassonav catheter, the patient went into afib.The physician feels that the issue is related to the catheter frequencies on the carto 3 system.Patient has fully recovered.
Additional Manufacturer Narrative
After an internal review, this event was reassessed as not mdr reportable.Cardioversion applied during a cardiac ablation procedure is not a medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.Rather, it is a well-known and commonly accepted alternative procedural step to achieve sinus rhythm.There was no extended hospitalization.As such, the h 6.Medical device problem code was updated to ¿appropriate term/code not available (a27)¿ which refers to ¿patient event - non serious¿.Since this event has already been reported to fda, biosense webster inc.Will continue to submit supplemental mdrs to fda with any updates even though this event is no longer considered mdr reportable.Therefore, the device evaluation details are being reported.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, deflection, contraction, and magnetic sensor functionality test of the returned device were following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No deflection issues were observed.The contraction mechanism was tested, and the loop was contracting within specifications.No issues were observed.The device was connected to the carto 3 system, and it was recognized; however, error 116 was displayed on the screen to an internal eeprom component failure.A deflection test was performed, and the curve was deflecting within specifications.The error 116 observed is unrelated to the reported event.The issue reported by the customer was not confirmed, however a magnetic error was observed during the product investigation.Product failure is multifactorial.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.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: 18840804
• Report Number: 2029046-2024-00732
• Device Sequence Number: 7280240
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D134301
• Device Lot Number: 31130064L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; NGEN RF GENERATOR, US; QDOT MICRO, UNI, TC, F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male