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

Catalog Number	D134901
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) procedure with a lasso nav catheter and observed foreign material at the tip of the catheter.During the procedure, after withdrawal of the catheter from the patient, foreign material was found at the tip of the catheter.A second catheter was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received stating there was no difficulty experienced while maneuvering the catheter or during the withdrawal.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 04-nov-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso nav catheter.During the procedure, after withdrawal of the catheter from the patient, foreign material was found at the tip of the catheter.A second catheter was used to complete the procedure.There was no adverse event reported on the patient.The device evaluation was completed on 20-nov-2024.The device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual analysis of the returned sample revealed a plastic-like material attached to the tip of the device.For this reason, a fourier transform infrared spectroscopy (ft-ir) analysis was requested, and it was concluded that the material observed shows the absorption bands for fluorinated polymer-based material, a polytetrafluoroethylene (ptfe) presumably a component of the inner wall of the sheath of a vizigo sheath.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material reported by the customer was confirmed.The ptfe particle could be related to the interaction of the catheter with the sheath during the procedure; however, this cannot be conclusively determined.The catheter instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath, when resistance is encountered.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.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: 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: 20157259
• Report Number: 2029046-2024-02983
• Device Sequence Number: 8259377
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: (01)10846835009651(17)270221(10)31256820L
• 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,Followup,Followup
• Report Date (Section B): 12/10/2024

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: 31256820L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 11/20/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/12/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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: ABBOTT SL1 SHEATH.
• Patient Sex: Unknown