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 Unable to Obtain Readings (1516); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure, as soon as the lasso was inserted into the body, it was visible on carto but the physician was not able to fam or acquire points from this catheter.Changing the cable was attempted and it was attempted to use 20b instead of 20a but these did not fix the problem.The issue was resolved when the catheter was replaced.There was no adverse event to the patient and the procedure was completed successfully without any patient consequence.Upon visual inspection of the returned complaint catheter, on june 3, 2014 bwi failure analysis lab noted ring #1 has some type of white material underneath the proximal side of ring 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 as soon as the lasso was placed into the body, it was visible on carto 3 but customer was not able to fam or acquire points from the catheter.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 to in order to identify the type of foreign material; the results demonstrated that the particle is made of barium sulfate and polyethylene.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.Due to this, catheter ods were measured and device was 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 damage rings 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: 3881210
• MDR Text Key: 4546755
• Report Number: 9673241-2014-00222
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113213
• 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,Followup
• Report Date: 05/13/2014

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 Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN_D-1343-01-S
• 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: 06/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1