MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-01-S

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5239407
• MDR Text Key: 32103338
• Report Number: 9673241-2015-00849
• Device Sequence Number: 1
• Product Code: DRF
• 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
• Report Date: 10/27/2015

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 Expiration Date: 05/31/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17255826L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1