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 Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

It was reported that during an afib ¿ paroxysmal procedure, that error 139 appeared on the carto3 system when the lasso nav eco was connected.The customer exchanged the cable with another reprocessed cable, exchanged catheter without resolution.The issue was resolved by exchanging the eco adaptor cable.The case was completed without any patient consequence.Upon receiving the product in biosense webster lab on july 2, 2014, it was noticed that ring #1 has white material underneath the proximal side, making this event reportable.

Manufacturer Narrative

Investigation is still in progress.A supplemental report on device evaluation will be submitted.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that error 139 appeared on the c3 system when the lasso nav eco was connected.Upon receipt, the catheter was visually inspected and it was found that ring 1 was damaged and had some white particle underneath.This condition was not originally reported on the complaint.A ft-ir test was performed in order to identify the type of foreign material, the results demonstrated that the particle is a polyethylene and barium sulfate based material.It is unknown how the ring was damaged and the origin of the foreign material.In addition, a corrective action has been opened to address and resolve this issue.The catheter outer diameters were measured and it was found within specifications.Then 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 damaged rings t from leaving the facility.The reported customer complaint cannot be 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: 3936979
• MDR Text Key: 4577573
• Report Number: 9673241-2014-00263
• 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: 04/04/2014

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: 16049578L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1