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

Model Number	D134903
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
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 catheter and a knotted loop issue occurred.It was reported that the lasso catheter was "twisting on itself" and the physician reported that the handle was not able to maneuver properly.When the catheter was replaced, the issue resolved.Replacement catheter requested.Sheath information was a merit 90-degree fixed sheath, 8.5 french.There was no detachment of any component.The statement "twisting on itself¿ was confirmed to mean that as the physician was clocking the catheter, the lasso loop became twisted and disfigured, not forming the normal loop shape.The loop/tip became unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.Image on fluoro is not available.The physician stated that the catheter was moving in the way he was accustomed to.The knotted loop issue is mdr reportable.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).
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.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
The device evaluation was completed on 01-feb-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco catheter and a knotted loop issue occurred.It was reported that the lasso catheter was "twisting on itself" and the physician reported that the handle was not able to maneuver properly.When the catheter was replaced, the issue resolved.Replacement catheter requested.Sheath information was a merit 90-degree fixed sheath, 8.5 french.There was no detachment of any component.The statement "twisting on itself¿ was confirmed to mean that as the physician was clocking the catheter, the lasso loop became twisted and disfigured, not forming the normal loop shape.The loop/tip became unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.Image on fluoro is not available.The physician stated that the catheter was moving in the way he was accustomed to.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed the device tip was observed knotted.A deflection test was performed, and no issues were observed.The knotted loop condition reported by the customer was confirmed and it is related to the physician clocking the catheter.A manufacturing record evaluation was performed for the finished device 30831546l number, and no internal actions related to the reported complaint condition were identified.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 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: 16064915
• Report Number: 2029046-2022-03248
• Device Sequence Number: 13958314
• Product Code: DRF
• UDI-Device Identifier: 10846835009675
• UDI-Public: 10846835009675
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2023

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: 06/20/2025
• Device Model Number: D134903
• Device Catalogue Number: D134903
• Device Lot Number: 30831546L
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 02/01/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/27/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: MERIT 90-DEGREE FIXED SHEATH, 8.5 FRENCH
• Patient Sex: Unknown