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	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter.The doctor reported that it felt like the catheter broke.The physician inserted the lasso catheter into the patient and the physician felt something has snapped in the catheter.The doctor stated ¿felt the catheter break¿.No known wires were exposed and no sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre shaped and a baylis 8.5fr sheath was used.The catheter was replaced, and the issue was resolved.There was no patient harm reported.This issue was assessed as a mdr reportable product malfunction.
Additional Manufacturer Narrative
The biosense webster, inc.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).
Additional Manufacturer Narrative
The device evaluation was completed on 13-jul-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter.The doctor reported that it felt like the catheter broke.The physician inserted the lasso catheter into the patient and the physician felt something has snapped in the catheter.The doctor stated ¿felt the catheter break¿.No known wires were exposed and no sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre shaped and a baylis 8.5fr sheath was used.The catheter was replaced, and the issue was resolved.There was no patient harm reported.Device evaluation details: the device was returned to biosense webster inc.(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 deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device 30779574l number, and no internal action related to the complaint was found during the review.The deflection 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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14692797
• Report Number: 2029046-2022-01313
• Device Sequence Number: 20492315
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 04/05/2025
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30779574L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: UNK BAYLIS 8.3FR SHEATH; UNK BRAND CATHETER
• Patient Sex: Unknown