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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter.The contraction was stuck.The lasso catheter would not open up and the lasso appeared to be stuck.They replaced the catheter and the issue was resolved.No patient consequences were reported.The knob and piston worked, the lasso itself would not open or close.The failure was found during use.There was no difficulty in removing the catheter from body.There was no rings, electrode or other physical damage observed at the distal end of the catheter.No additional procedure was require to remove the catheter.Contraction stuck is mdr-reportable.
Additional Manufacturer Narrative
On (b)(6)2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter.The contraction was stuck.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the lasso nav variable eco.Deflection & contraction testing was performed following bwi procedures.The deflection mechanism pass the test.The curve met the specification.And the contraction mechanism was within specifications.The shape looks in good normal conditions.A manufacturing record evaluation was performed for the finished device 30588477l number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The event described could not be confirmed as the device was found with the deflection curve and lasso contraction & within specifications.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 (b)(6) 2022, 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).

• 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: 14460558
• Report Number: 2029046-2022-01077
• Device Sequence Number: 11933670
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/30/2022

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: 06/17/2024
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30588477L
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 05/20/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/10/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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: CARTO 3 SYSTEM; LASSO NAV CATHETER
• Patient Sex: Unknown