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

Model Number	D134301
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a afib - persistent ablation procedure with a lasso® nav eco variable catheter.It was reported that during mapping of the left atria, the lasso nav catheter entangled with a chordae of the mitral valve.It took a great deal of effort and time for the physician to manage to remove the catheter from the valve's chordae.Surgery was delayed due to the reported event for 60 minutes.Procedure was successfully completed.No patient consequences were reported.The event happened on the same day with the current complaint: (b)(6) 2023.This adverse event was discovered during use of biosense webster products.The patient did not suffer any notable consequence; however, the procedure was delayed almost an hour and if the hospital surgery department was ready to intervene if the physician was not able to remove the catheter from the chordae.The physicians opinion on the event is that the product was somehow "prone to hanging.".The patient was reported to be in good condition.Medical device entrapment with excessive manipulation.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).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 reference number: (b)(4).
Additional Manufacturer Narrative
On 2-may-2023, the bwi product analysis lab was received 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.However, a video was received for evaluation following biosense webster's procedures.Device investigation details: according to the video provided by the customer, it looks like the lasso catheter was entangled/knotted with itself, this condition is related to the customer complaint.A manufacturing record evaluation was performed for finished device number 30982620l, and no internal actions related to the reported complaint condition were identified.The instructions for use contain the following contraindication: ¿ use of the catheter may not be appropriate for use in patients with prosthetic valves.The customer complaint was confirmed based on the video received.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
On 22-jun-2023, the product investigation was completed.It was reported that a patient underwent a afib - persistent ablation procedure with a lasso® nav eco variable catheter.It was reported that during mapping of the left atria, the lasso nav catheter entangled with a chordae of the mitral valve.It took a great deal of effort and time for the physician to manage to remove the catheter from the valve's chordae.Surgery was delayed due to the reported event for 60 minutes.Procedure was successfully completed.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.The device was inspected, and the lasso loop was found deformed with no internal parts exposed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30982620l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer can be confirmed however, the entrapment issue and damage on the lasso loop could be related to the manipulation of the device during procedure.In addition, 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 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: 16845148
• Report Number: 2029046-2023-00932
• Device Sequence Number: 20714665
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 01/16/2026
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30982620L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 06/22/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/25/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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
• Patient Sex: Male