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

Catalog Number D134301

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a lasso® nav eco variable catheter and the spiral of the catheter broke.The loop of the catheter was blocked.It was not possible to manipulate the catheter.So the medical team changed it and everything went well with the remainder of the procedure.There were no patient consequences reported.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31193647l and no internal action related to the complaint was found during the review.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).

Manufacturer Narrative

On 6-may-2024, the bwi product analysis lab received the device for evaluation.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).Per internal review on 8-may-2024, it was identified that the manufacture date had the incorrect year on the initial report.The g4 manufacture date has been corrected to 13-nov-2023.

Manufacturer Narrative

On 17-may-2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a lasso® nav eco variable catheter and the spiral of the catheter broke.The loop of the catheter was blocked.It was not possible to manipulate the catheter.So the medical team changed it and everything went well with the remainder of the procedure.There were no patient consequences reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and deflection and contraction evaluation of the returned device was performed following bwi procedures.Visual analysis revealed that the loop of the catheter was deformed.Then, a deflection and contraction testing were performed, and the catheter failed both tests, but the contraction mechanism wasn't stuck.Since the catheter failed the deflection and contraction test, a manufacturing meeting was performed and it was determined that the puller wire was observed bent inside the tip creating the deflection/contraction issues however, this issue was determined as not related to the manufacturing process since evidence of properly manufacturing assembly was found.A manufacturing record evaluation was performed for the finished device number lot 31193647l and no internal action related to the complaint was found during the review.  the deformed loop could be related to the broken and contraction stuck reported by the customer therefore, customer complaint was confirmed.The potential cause of the observed issues could be related to the manipulation of the device during procedure however, this cannot be conclusively determined.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.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 reference number: (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: 19085017
• MDR Text Key: 340229538
• Report Number: 2029046-2024-01183
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: D134301
• Device Lot Number: 31193647L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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