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

Model Number D134301

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a lasso® nav eco variable catheter, and a bad no ecg signal on all channels occurred.Initially, it was reported that the carto 3 system displayed an unknown error with a notification of "current leakage error.When they disconnected the catheters from the piu, the issue was resolved.However, the issue reoccurred when connecting the pentaray catheter and the lasso catheter to the piu.They replaced the lasso catheter and the pentaray catheter at the same time and the issue was resolved.The procedure was continued, and no adverse patient consequence was reported.The current leakage is not mdr reportable.This issue is highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.On 03-may-2023, additional information was received which made the event reportable.It was confirmed that the notification was accompanied by a loss of all ecgs.The noise was observed on all channels, on both the carto 3 system and the recording system.The bad/no ecg on all channels is mdr reportable.

Manufacturer Narrative

The device was returned to biosense webster (bwi) for evaluation.A visual inspection, magnetic sensor functionality, and electrical tests of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly.No magnetic nor current leakage issues were observed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device 30914148l, and no internal action was found during the review.The electrical and current leakage issues reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mrn # for product code d134301 for lasso® nav eco variable catheter.(2) mfr # 2029046-2023-01177 for product code d128211 for pentaray nav high-density mapping eco catheter.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Type of Device: 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: 17027846
• MDR Text Key: 317443716
• Report Number: 2029046-2023-01178
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• 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: 05/30/2023

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 Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30914148L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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: LASSO NAV 2515,22P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; PENTARAY NAV ECO 7FR, D, 2-6-2