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

Model Number D-1263-07-S

Device Problems Radio Signal Problem (1511); Device Displays Incorrect Message (2591)

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

Event Date 08/25/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 navigational variable lasso catheter and a bad / no ecg all channels (bs and ic) issue occurred.All the intracardiac ecg¿s and body surface ecg¿s on both the carto 3 rmt system and the recording system were lost when this catheter was plugged into the patient interface unit (piu).The piu was rebooted and the catheter was reseated with no resolution.The issue was resolved by exchanging the catheter.They had ecgs for anesthesia.There were no ablation catheters in at the time that they had the issue with the signals.The procedure was completed without patient consequence.The loss of all signals ic and bs on both the carto 3 rmt system and the recording system is indicative of a reportable event.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

Correction to previously submitted 3500a.It was confirmed that the patient¿s heart rhythm was able to be monitored through an ecg signal visible on hospital equipment.Carto ifu states that in the event of carto failure the bs ecg will be displayed on other hospital equipment.Since the physician was able to monitor the patient¿s heart rhythm, patient safety was not at risk.This complaint was reassessed as not reportable.(b)(4) it was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 navigational variable lasso catheter and a bad / no ecg all channels (bs and ic) issue occurred.All the intracardiac ecg¿s and body surface ecg¿s on both the carto 3 rmt system and the recording system were lost when this catheter was plugged into the patient interface unit (piu).The piu was rebooted and the catheter was reseated with no resolution.The issue was resolved by exchanging the catheter.They had ecgs for anesthesia.There were no ablation catheters in at the time that they had the issue with the signals.The procedure was completed without patient consequence.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.

• Brand Name: WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4104532
• MDR Text Key: 4720637
• Report Number: 9673241-2014-00357
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/25/2014

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 Expiration Date: 06/30/2017
• Device Model Number: D-1263-07-S
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 17060689M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2014
• 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