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

Catalog Number	D134901
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) procedure with a lasso® nav eco catheter for which biosense webster¿s product analysis lab (pal) identified the first electrode detached from its position and observed lifted the electrode.During the procedure, the device was recognized by the carto but the catheter electrode was not visualized on the carto system.A second device was used to complete the procedure.There was no adverse event reported on patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 11-jun-2024, the first electrode was detached from its position and observed lifted the electrode.The event was originally considered non-reportable, however, bwi became aware of the first electrode detached from its position and observed lifted the electrode on 11-jun-2024 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 04-jun-2024.The device evaluation was completed on 11-jun-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and functional test of the returned device were performed following bwi procedures.Visual analysis revealed that the first electrode was detached from its position and observed lifted the electrode.A magnetic sensor functionality test was performed, the catheter was recognized, and no error code was observed, however, the first electrode was visualized in black color, and this condition could be related to the open circuit.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The visualization issue reported by the customer was confirmed.The potential cause of the electrode damage could not be established.Carto3 instruction for use (ifu) recommendation: do not introduce the lasso® nav catheter tip folded into the guiding sheath.The lasso® nav catheter is recommended for use with an 8 fr atraumatic soft tipped guiding sheath.Note: do not use the lasso® nav catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿first electrode was detached from its position and observed lifted the electrode¿.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the customer¿s reported ¿catheter electrode was not visualized ¿.Manufacturer¿s reference number: (b)(4).

• 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: 19689546
• Report Number: 2029046-2024-02280
• Device Sequence Number: 8122889
• 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
• Report Date (Section B): 07/08/2024

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 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: 06/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK_CARTO 3
• Patient Sex: Unknown