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

Model Number D-1343-02-S

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso® nav eco variable catheter and a magnetic sensor error was displayed on the carto 3 system.The cable was exchanged without success.The catheter was then exchanged and the issue resolved.The procedure was completed successfully without patient consequence.This event is being reported due to the damage found on ring # 3 (lifted up on proximal side and sharp edge) when the product complaint was being inspected, as this might be a potential risk to the patient.The awareness date was updated due to the finding from failure analysis lab, from may 12th to may 27th of 2014.The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a lasso® nav eco variable catheter and a magnetic sensor error was displayed on the carto 3 system.The cable was exchanged without success.The catheter was then exchanged and the issue resolved.The procedure was completed successfully without patient consequence.This event is being reported due to the damage found on ring # 3 (lifted up on proximal side and sharp edge) when the product complaint was being inspected, as this might be a potential risk to the patient.Upon receipt, the catheter was visually inspected and found that ring # 3 was lifted up.This condition was not originally reported on the complaint.It is unknown how the ring was damaged.An internal corrective action has been opened to investigate this type of issue.Due to this condition, catheter ods were measured and device was found 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 damage rings from leaving the facility.The customer complaint was not confirmed.

• 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: 3875656
• MDR Text Key: 4460906
• Report Number: 9673241-2014-00219
• 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
• Report Date: 05/12/2014

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: 11/30/2016
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 16023275L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2013
• 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