BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
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Model Number D-1343-01-S |
Device Problems
No Display/Image (1183); Device Displays Incorrect Message (2591)
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Patient Problem
No Code Available (3191)
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Event Date 10/27/2015 |
Event Type
malfunction
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Manufacturer Narrative
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No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: ez steer thermocool sf nav catheter (model# d-1313-04-s, lot# 17271444l) c3 interface cable ¿ therapeutic (model# d-1286-03-s lot# 105039.(b)(4).
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Event Description
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It was reported that a patient underwent a right sided atrial flutter procedure with a carto 3 system and two lasso® 2515 nav eco variable catheters a procedure cancellation occurred.During the procedure, the lasso catheter displayed a magnetic sensor error.The catheter was changed and the second lasso catheter loop would not display therefore the catheter could not be used for fast anatomical mapping.Error 371 "mapping electrodes not available" was seen.More than 30 minutes of troubleshooting was done, including cable and catheter changes, moving the lasso from 20a to 20b, rebooting the piu and the workstation, using a default template, starting a new study and re-initializing.An error 370 ¿cannot acquire points with mapping catheter¿ was also displayed.The issue resolved with a piu reboot.The right sided atrial flutter was completed however the atrial fibrillation (afib) portion of the procedure was aborted due to the system issues.Upon request additional information was received on the event.None of the catheters or cables used were reprocessed.A transseptal puncture was performed and the patient was under general anesthesia.The piu was rebooted 5 or 6 times to clear the error.The afib portion was aborted and they were only able to treat the atrial flutter because the physician no longer trusted the carto 3 system.This event is indicative of a reportable event because the patient was under general anesthesia in combined with a transseptal puncture and because the physician no longer trusted the carto 3 system.The carto 3 system is the suspected device of the procedure cancellation in conjunction with the sensor error and bad sensor of the lasso catheter.Therefore both lasso catheters and the carto 3 system will also be reported separately.
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