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

Model Number	D134302
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a lasso¿ nav eco variable catheter and an issue with the catheter being stuck in a fully contracted position occurred.The smarttouch catheter got stuck several times in the lasso.Instead of pulling back st, lasso moved with a lot of force.The lasso stopped curving the way it should.No adverse patient consequences were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 30-jul-2021.The device evaluation was completed on 06-aug-2021.It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter and an issue with the catheter being stuck in a fully contracted position occurred.The smarttouch catheter got stuck several times in the lasso.Instead of ¿pulling back st, lasso moved with a lot of force.¿ the lasso stopped curving the way it should.No adverse patient consequences were reported.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the lasso nav eco.Deflection and contraction testing was performed, the product passed the test in accordance with biosense webster inc.(bwi) procedures.The catheter was working correctly, and no deflection nor contraction issues were detected during the analysis.A manufacturing record evaluation was performed for the finished device 30508085l number, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the as the device performed without any deflection issues.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 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).

• 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
• MDR Report Key: 12215339
• Report Number: 2029046-2021-01170
• Device Sequence Number: 3779340
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 02/07/2024
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30508085L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SMARTTOUCH CATHETER