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

Catalog Number	D140401
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and a microscopic examination of the returned device were performed.Visual inspection revealed that the shaft was bent.Further analysis under image magnification revealed that one of the electrodes was lifted with internal components exposed.The impeded device and user error reported were confirmed.The damages observed in the shaft and the electrode may have caused the device to get stuck or the damage could have occurred during device removal.The root cause is related to user error as the catheter was used in a non-compatible device.The ifu states: the lassostar¿ nav¿ circular mapping catheter is a circular diagnostic catheter that has been designed to facilitate ablation of cardiac arrhythmias by mapping the pulmonary veins.It can be deployed in the right or left atrium through a compatible 8.5 f to 13.5 f deflectable guiding sheath.To prevent damage to the shaft of the catheter, ensure that at least half of the catheter is inserted through the sheath before sliding the insertion tool back toward the connector.Do not use excessive force to advance or withdraw the catheter if resistance is encountered.As part of johnson & johnson medtech'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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) cardiac procedure which included the use of a lassostar nav for which biosense webster¿s product analysis lab (pal) identified that one of the electrodes was lifted with internal components exposed.Initially, it was reported that when the physician attempted to remove the lassostar catheter through the cryo sheath, it was unable to be removed.The sheath and catheter were then removed from the body together.The lassonav distal tip was lodged in the sheath towards the proximal end of the sheath at the hub.After the case, the scrub tech was able to pull and remove the catheter from the sheath.No damage was noted on the catheter and no adverse patient consequence was reported.The event was assessed as non mdr reportable.The biosense webster, inc.Pal received the device and per the evaluation completion, the shaft was observed bent and one of the electrodes was lifted with internal components exposed.This was assessed as mdr reportable with an awareness date of 09-nov-2024.
Additional Manufacturer Narrative
During an internal review on 13-mar-2025, it was noted that the correct imdrf code for this event is off-label use (a2304).Therefore, h6.Medical device problem code has been updated.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: LASSOSTAR 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: 20858453
• Report Number: 2029046-2024-03904
• Device Sequence Number: 20989600
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: (01)10846835020335(17)250522(10)31302673L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211219
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 05/22/2025
• Device Catalogue Number: D140401
• Device Lot Number: 31302673L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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
• Patient Sex: Unknown