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

Catalog Number	D134901
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.The product investigation was completed based on received photographs of the complaint device.Device investigation details: a picture was received for evaluation following johnson & johnson medtech's procedures.According to pictures provided by the customer, the tip of the catheter was observed damaged with components exposed.However, the visualization issue cannot be determined based on the images provided.A device history record evaluation was performed for the finished device 31338846l, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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 or Problem Description
It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a lasso® nav eco catheter and during the operation, the device was recognized by the carto but the catheter was not visualized on the carto system.A second device was used to complete the operation.Post procedure, the medical team identified that internal components were exposed on the tip.There was no adverse event reported on patient.

• Brand Name: LASSO® NAV ECO 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: 20904803
• Report Number: 2029046-2024-03966
• Device Sequence Number: 9132978
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: (01)10846835009651(17)270711(10)31338846L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: D134901
• Device Lot Number: 31338846L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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: UNK CARTO SYSTEM.
• Patient Sex: Unknown