MAUDE Adverse Event Report: STRYKER LASSO CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/01/2013

Event Type  malfunction  

Event Description

This letter is to inform you of this event as the suspect device (stryker -reprocessed lasso catheter) is not manufactured or imported by biosense webster, inc.We had already sent to you a notification on october 31, 2013.Additional information was received on october 31, 2013.Below is all the information that we have received on this event.It was reported that the territory manager was notified on 10/17/2013 that a during a pvi case on (b)(6) 2013, the physician noticed noise on the ecg and then it went blank.After reviewing fluoro, it was noticed that one of the electrodes of the reprocessed lasso catheter was floating in the left atrium.The territory manager stated that the electrode was aspirated successfully through the agillis sheath.There was no patient intervention.The following bwi devices were in use: stockert (st-3324), coolflow pump (04158),catheter ( di7tcflrt lot unknown-disposed), coolflow tubing (catalog cft001 lot unknown) and a reprocessed acunav catheter (reprocessed by stryker).Upon request, additional information was provided on the event.The patient was fine following the successful retrieval of the loose electrode piece.The attending physician felt the patient could be at risk while the electrode piece was floating loose in the left atrium prior to successful retrieval of the loose piece.They are unable to clarify the signal noise request as there is not enough information.It was mentioned by the lab manager that the physician performing the procedure "noticed noise" at the time of the event that caught his attention.It is unknown where the noise specifically showed up.It was unknown if the physician was still able to interpret the noise.It is unknown if/how the noise played a role in the procedure during the time that the electrode came loose from the reprocessed lasso catheter.This procedure was performed with a st.Jude navx system.The procedure was stopped following the successful retrieval of the loose electrode piece.Additional information was received on october 31, 2013.The procedure was stopped after the incident, but the physician considered the pulmonary vein isolation (pvi) successful.Therefore, there was no need to reschedule the procedure.The patient was under general anesthesia for approximately 4hours and 55 minutes.The procedure was performed in the left atrium.There was a transseptal puncture performed prior to the case cancellation.The case cancellation was only because of the product issue, but the issue occurred at the end of the procedure so the physician considered the ablation successful.The physician did not consider that cancelling the procedure caused a potential risk to this patient.The patient did not require extended hospitalization.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LASSO CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17529040
• MDR Text Key: 321403727
• Report Number: MW5135969
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1