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

Model Number D-1290-01-S

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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 product: smart touch bidirectional catheter (model# d-1327-01-s lot# 17268645m).(b)(4).

Event Description

It was reported that a patient underwent a procedure with a lasso 2515 nav variable catheter and a noise issue occurred.After connecting the lasso to the piu, both carto and pruka recording system had a severe noise issue on both electrocardiograms (ecg) and intracardiac signal and the physician couldn't not read signals at all.When the lasso cable was removed from the piu, the noise issue was gone.The cable was changed to a new one and the system was turned off then back on but that did not resolve the issue.The catheter was changed to a new one and the procedure was completed successfully with no patient consequence.Upon request additional information was received on the event.One lead, possibly lead iii was available to monitor the patient's heart rhythm.However, there is no report of an anesthesia monitor or a defibrillator to monitor the patient's heart rhythm.The anesthesia monitors usually have five leads and defibrillators have two leads.In addition, the event description indicated that the physician could not read the signals at all.As such, even though one lead was available, there is still no indication that the patient could be effectively monitored during this event.As such, this event is being conservatively reported since a lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm.During the same procedure there was also a not reportable magnetic sensor error on the smart touch catheter.

• Brand Name: LASSO 2515 NAV VARIABLE CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 5191413
• MDR Text Key: 30422177
• Report Number: 9673241-2015-00790
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K081258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: D-1290-01-S
• Device Catalogue Number: LN222515CT
• Device Lot Number: 17194949L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2015
• 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