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 Codes	Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter and the device became stuck within itself.Lasso got stuck on itself.Wouldn't come into sheath or out of chamber.It was stuck in both wide and small position but the knob was still free moving.When removed and examined the shaft seemed to be damaged.Damage to the base of the lasso loop.Looks like it was extremely torqued and deformed.
Additional Manufacturer Narrative
On 7-feb-2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter and the device became stuck within itself.Lasso got stuck on itself.Wouldn't come into sheath or out of chamber.It was stuck in both wide and small position but the knob was still free moving.When removed and examined the shaft seemed to be damaged.Damage to the base of the lasso loop.Looks like it was extremely torqued and deformed.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and deflection and contraction evaluation of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Deflection and contraction testing were performed, and contraction mechanics did not contract correctly, but it wasn't stuck.Due to this condition, a manufacturing meeting was performed, and the investigation results determined that the catheter issue found on the device is not manufacturing related.The most likely cause of this failure is related to the handling of the device during the procedure, as it was found that the curve of the spine cover (lasso loop) was twisted due to excessive force during the process of the catheter contraction mechanism.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The contraction issue observed could be related to the contraction and knotted issue reported by the customer.It should be noted that product failure is multifactorial.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
• 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: 18523150
• Report Number: 2029046-2024-00186
• Device Sequence Number: 12798365
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/15/2024

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: 07/31/2026
• Device Catalogue Number: D134301
• Device Lot Number: 31120863L
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 02/29/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/09/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: AGILIS SHEATH.
• Patient Sex: Unknown