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 Problems Failure to Read Input Signal (1581); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that during the procedure, after connecting lasso nav catheter, all signals was contaminated with noise.Upon follow up, bwi received the information on (b)(6) 2014 (which changed the alert date) that showed the signal loss occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardiac) recordings on both carto and ep recording systems at the same time.

Manufacturer Narrative

(b)(4).

• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3612229
• MDR Text Key: 4069732
• Report Number: 9673241-2014-00032
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K081258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: D-1290-01-S
• Device Catalogue Number: LN222515CT
• Device Lot Number: 15759190L
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2013
• Type of Device Usage: Initial
• Patient Sequence Number: 1