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 Collapse (1099); Device Displays Incorrect Message (2591); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

During an atrial fribrillation procedure, it was reported that an intermittent magnetic sensor error was displayed on carto 3 system with this lasso® nav eco variable catheter.The cable was exchanged and they switched to a different port of the patient interface unit (piu) with no resolution.No spare catheter was available therefore; the same lasso with intermittent issue was used to complete the case.There were no patient consequences.On (b)(4), the product returned was reviewed in our failure analysis lab and found damages (sharp edges and squashed) in ring # 1 and ring # 5.This condition was reviewed and determined to be a potential risk to the patient.Therefore, this complaint became reportable.Awareness date changed from (b)(6) 2014.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) during an atrial fibrillation procedure, it was reported that an intermittent magnetic sensor error was displayed on carto 3 system with this lasso nav eco variable catheter.The cable was exchanged and they switched to a different port of the patient interface unit (piu) with no resolution.No spare catheter was available therefore; the same lasso with intermittent issue was used to complete the case.There were no patient consequences.On march 17th, the product returned was reviewed in our failure analysis lab and found damages (sharp edges and squashed) in ring # 1 and ring # 5.The catheter was visually inspected and found ring # 1 and # 5 were damaged.This condition was not originally reported on the complaint.It is unknown how the rings were damaged.An internal corrective action has been created to investigate 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 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: 3718278
• MDR Text Key: 4335687
• Report Number: 9673241-2014-00122
• 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: 03/03/2014

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: 03/03/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2014
• 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