MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-1263-04-S

Device Problem Noise, Audible (3273)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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).

Event Description

It was reported that a patient underwent an atrial tachycardia procedure with a webster cs catheter with ez-steer technology and a noise issue occurred.Noise from all leads was displayed on the carto 3 system and the recording system.The electrocardiogram (ecg) leads and cable were replaced with no resolution.When the catheter was replaced, the issue resolved.Multiple attempts have been made to obtain additional information on this complaint.However, no further information has been made available.Although it is standard practice to have external ecg monitors during these procedures, this is being conservatively reported because the presence of ecg signal from an external monitor could not be confirmed.The inability to monitor the patient's ecg rhythm while devices are intra cardiac might lead to undetected cardiac rhythm that could be life threatening, therefore this event is mdr reportable.

• Brand Name: WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5994804
• MDR Text Key: 56975605
• Report Number: 9673241-2016-00652
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K090898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2016

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: 06/30/2019
• Device Model Number: D-1263-04-S
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: 17526580M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2016
• 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