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

Model Number D-1290-02-S

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation procedure the noise was observed on ic, and bs channels on both carto and ep recording system at the same time.The customer changed that catheter and cable; however the issue did not resolved.The issue was resolved by changing second catheter and the case was completed without any patient consequence.Upon following up with the customer, bwi received additional information that stated the anesthesia machine did not have the correct filter so it had noise too.Since the physician did not have any signal available to monitor the patient¿s heart rhythm this complaint is assessed as reportable event.

Manufacturer Narrative

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.(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: shahe garabedian ; 9098397362
• MDR Report Key: 4733095
• MDR Text Key: 15904362
• Report Number: 9673241-2015-00242
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1290-02-S
• Device Catalogue Number: LN122515CT
• Device Lot Number: 17079891L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1