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 Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, it was reported that magnetic distortion and magnetic sensor error were being displayed on the carto 3 system.Troubleshooting was performed with no resolution: replacing the cable with a brand new cable two times and replacing the catheter.The procedure was completed successfully (conventionally) with no patient consequences.The customer requested replacement for the cables (carto® 3 system eco interface cable) and catheter used during troubleshooting (lasso® nav eco variable catheter) on (b)(4), failure analysis lab found white foreign material underneath ring # 2 on the proximal side of the lasso® nav eco variable catheter.Due to this finding and the potential risk to the patient, it was determined for this complaint to be reportable.Awareness date changed from (b)(6) 2014.

Manufacturer Narrative

The device investigation is still in progress.(b)(4).

Manufacturer Narrative

A) pending additional information from the analysis results that were submitted on july 1st as a supplemental # 1 (9673241-2014-00193): the customer complaint was not confirmed.As for the damage ring/foreign particles found on the product returned, an internal corrective action has been opened to investigate it.(b)(4).

Manufacturer Narrative

(b)(4) during an atrial fibrillation procedure, it was reported that magnetic distortion and magnetic sensor error were being displayed on the carto 3 system.Troubleshooting was performed with no resolution: replacing the cable with a brand new cable two times and replacing the catheter.The procedure was completed successfully (conventionally) with no patient consequences.The customer requested replacement for the cables and catheter used during troubleshooting.On may 5th, failure analysis lab found white foreign material underneath ring # 2 on the proximal side of the lasso nav eco variable catheter.Upon receipt, the catheter was visually inspected and found that ring # 2 was damaged and had some white particle underneath.This condition was not originally reported on the complaint.A ft-ir test was performed to in order to identify the type of foreign material, the results demonstrated that the particle is mainly composed of polyethylene and barium sulfate.It is unknown how the ring was damaged and the origin of the foreign material.An internal corrective action has been opened to investigate and address this type of issue.Catheter ods were measured and the device was within specifications.Per the reported event, the catheter was evaluated for eeprom, carto 3, 4 khz and calibration functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.

• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3812260
• MDR Text Key: 4368959
• Report Number: 9673241-2014-00193
• 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,Followup,Followup
• Report Date: 04/22/2014

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: 01/31/2017
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 16050302L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/01/2014; 07/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2014
• 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