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 Problem Signal Artifact/Noise (1036)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, there was a lot of noise in all signals when the catheter was connected.Changing the catheter and rebooting the carto system could not resolved the issue therefore the case was cancelled.Another case was performed with carto after 2 days and the carto system worked fine.The customer stated probably the catheter did not work properly.Upon following up with the customer, it was stated that the signal interference (noise) was observed on both ep recording system and carto.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.A transseptal puncture was performed prior to the case cancellation and the patient was under general anesthesia for 3 hours.The physician considered cancelling the procedure caused a potential risk to this patient since there was no visibility of any signal, so with lasso inside it could be a risk to the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturer ref # (b)(4).It was reported that during an atrial fibrillation (afib) procedure, there was a lot of noise in all signals when the catheter was connected.Changing the catheter and rebooting the carto system could not resolved the issue therefore the case was cancelled.Another case was performed with carto after 2 days and the carto system worked fine.The customer stated probably the catheter did not work properly.Upon following up with the customer, it was stated that the signal interference (noise) was observed on both ep recording system and carto.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.A transseptal puncture was performed prior to the case cancellation and the patient was under general anesthesia for 3 hours.The physician considered cancelling the procedure caused a potential risk to this patient since there was no visibility of any signal, so with lasso inside it could be a risk to the patient.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance and it was found within specifications.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.The customer complaint cannot be confirmed.

Manufacturer Narrative

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.(b)(4).

• 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 ; 9098398483
• MDR Report Key: 4532177
• MDR Text Key: 5357031
• Report Number: 9673241-2015-00115
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 02/02/2015

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: 07/31/2017
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17060243L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2015; 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1