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

Catalog Number D134301

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a lasso® nav eco variable catheter and the torque to control the loop failed.After mapping with the lasso® nav eco variable catheter, he tried to release the loop and put it in vein to check the signal for ablation, but the torque to control the loop failed, so he was able to replace it with a new catheter and successfully complete the procedure.There was no patient consequence.

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a lasso® nav eco variable catheter and the torque to control the loop failed.After mapping with the lasso® nav eco variable catheter, he tried to release the loop and put it in vein to check the signal for ablation, but the torque to control the loop failed, so he was able to replace it with a new catheter and successfully complete the procedure.There was no patient consequence.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 30515694l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a lasso® nav eco variable catheter and the torque to control the loop failed.After mapping with the lasso® nav eco variable catheter, he tried to release the loop and put it in vein to check the signal for ablation, but the torque to control the loop failed, so he was able to replace it with a new catheter and successfully complete the procedure.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation on 30-apr-2024 and the evaluation has been completed.Visual inspection, deflection, and contraction tests of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Deflection and contraction tests were performed, and the curve was deflecting within specifications.The loop contract correctly, no problem with the loop was observed.No deflection or contraction issues were observed.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 could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain (ifu) the following warning and precaution: always pull the thumb knob back to straighten the catheter tip before insertion or withdrawal of the catheter.To avoid potential damage to anatomical structures, do not attempt to pull the catheter, or withdraw it into the sheath, with the loop in a contracted position.The loop should be fully relaxed (handle grip rotated fully to the left) to minimize tension applied to the nitinol structure.As part of biosense webster¿s 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 ref.# (b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Type of Device: 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: 18775156
• MDR Text Key: 337081118
• Report Number: 2029046-2024-00622
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: D134301
• Device Lot Number: 30515694L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/25/2024
• Supplement Dates Manufacturer Received: 03/04/2024; 04/30/2024
• Supplement Dates FDA Received: 03/18/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1