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

Model Number D134301

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

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 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.

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).

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
• Type of Device: 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 ; 646591-798
• MDR Report Key: 14460558
• MDR Text Key: 294533750
• Report Number: 2029046-2022-01077
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 05/20/2022; 05/20/2022
• Supplement Dates FDA Received: 06/10/2022; 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; LASSO NAV CATHETER