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

Catalog Number	D134301
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 eco variable catheter.Immediately after insertion, became inoperability at the timing when decreased the ring diameter immediately.The issue was resolved by replacing the lasso® nav eco variable catheter.Patient was unaffected.The procedure was completed without patient's consequence.Additional information was received.There was some resistance.There was no ring, electrode or other physical damage observed at the distal end of the catheter.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 14-mar-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 eco variable catheter.Immediately after insertion, became inoperability at the timing when decreased the ring diameter immediately.The issue was resolved by replacing the lasso® nav eco variable catheter.Patient was unaffected.The procedure was completed without patient's consequence.Additional information was received.There was some resistance.There was no ring, electrode or other physical damage observed at the distal end of the catheter.The investigation was completed on 08-may-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A contraction test was performed, and it was observed that the mechanism was not contracting correctly.For this type of issue, a manufacturing meeting was performed and it was concluded that the puller wire of the contraction mechanism was broken.Since the process has control points to check the deflection and contraction, this complaint is not related to the manufacturing process.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The contraction issue reported by the customer was confirmed since a broken contraction puller was found during the meeting.The potential cause of the puller wire broken could be related to the excessive force during the usage of the device.The instructions for use (ifu) contain the following recommendations: always pull the thumb knob of the catheter back before insertion or withdrawal to assure that the catheter tip assumes its straight position.This product issue will be addressed through bwi¿s quality system.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 ECO VARIABLE 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: 18882376
• Report Number: 2029046-2024-00798
• Device Sequence Number: 16912681
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/04/2024

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: D134301
• Device Lot Number: 31126449L
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 05/08/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/19/2024; 06/04/2024
• 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: SWARTZ SL0 8.5FR SHEATH
• Patient Sex: Unknown