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

Catalog Number	D134901
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to biosense webster (bwi) for evaluation.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed that electrode #1 was lifted with sharp edges.No other damage was observed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.The lifted electrode observed could be related to the electrical issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use contain the following recommendation: the catheter is recommended for use with an 8 fr atraumatic soft tipped sheath.Confirm compatibility of the catheter with the guiding sheath by fully inserting and withdrawing the catheter through the irrigated sheath before clinical use.If excessive force is required or interference between the catheter and sheath is observed, use an alternate guiding sheath to avoid damaging the catheter or sheath.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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a lasso nav catheter and there was electrocardiogram (ecg) signal interference.During the operation, the signal interference (noise) was observed on all body surface and intracardiac ecg channels.A second device was used to complete the operation.There was no adverse event reported on the patient.This event was originally assessed as not mdr reportable.The device was received for analysis, and it was discovered that electrode #1 was lifted with sharp edges.This finding is mdr reportable.

• Brand Name: LASSO NAV
• 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: 19710514
• Report Number: 2029046-2024-02304
• Device Sequence Number: 11572934
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: 10846835009651
• 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

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 Expiration Date: 08/14/2026
• Device Catalogue Number: D134901
• Device Lot Number: 31129689L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Patient Sex: Unknown