MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1220-81-S

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.As lot # 16078333l was provided, the device history record(s) 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).

Event Description

It was reported that a patient underwent a procedure with a lasso electrophysiology catheter with auto id and noise occurred at all electrocardiograms when catheter was connected.Furthermore, after the cable was changed noise occurred at electric potentials 11 and 12 as well as electrode 11 was displayed black on carto screen.Issue resolved by replacing the catheter to another one.The procedure was completed without patient's consequence.Follow up investigation was performed to clarify the event and it was informed that noise was observed on all intracardiacs and bodysurface electrocardiograms.However, no information was provided regarding the system displaying the noisy signals.Therefore, this event is being reported conservatively since lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
• 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 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 5000466
• MDR Text Key: 25350045
• Report Number: 9673241-2015-00519
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/21/2015

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: 02/28/2017
• Device Model Number: D-1220-81-S
• Device Catalogue Number: D7L2020CT
• Device Lot Number: 16078333L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2014
• 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