MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1260-04-S

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

During an atrial flutter procedure, it was reported that the ez steer¿ nav ds bi-directional electrophysiology catheter on the carto 3 system appears to be moving in a reverse direction.In the anterior-posterior view, as the catheter was advancing in the right atrium, the catheter was moving to the left.Troubleshooting was performed and the issue was resolved by replacing the catheter to do further mapping.There were no patient consequences and the procedure was completed successfully.On (b)(6), failure analysis lab found char on the distal end of the tip dome, on the proximal end of the tip dome, on the distal side of ring # 1 and other places of the catheter.Each char size (average) was approximately 1.5 millimeters.Based on these findings, it was determined for this complaint to be reportable due to the potential risk to the patient.Awareness date changed from (b)(6) 2014.

Manufacturer Narrative

The device investigation is still in progress.(b)(4).

Manufacturer Narrative

(b)(4) during an atrial flutter procedure, it was reported that the ez steer nav ds bi-directional electrophysiology catheter on the carto 3 system appears to be moving in a reverse direction.In the anterior-posterior view, as the catheter was advancing in the right atrium, the catheter was moving to the left.Troubleshooting was performed and the issue was resolved by replacing the catheter to do further mapping.There were no patient consequences and the procedure was completed successfully.On march 21st, failure analysis lab found char on the distal end of the tip dome, on the proximal end of the tip dome, on the distal side of ring # 1 and other places of the catheter.Each char size (average) was approximately 1.5 millimeters.The returned device was visually inspected and char was found close to the tip dome.This condition was not reported by the customer.Per the reported event, the catheter was tested and passed eeprom and recalibration check test, but failed carto 3 test due to reversed icon was detected during mapping.A recalibration test was performed and the catheter passed.After this, the catheter was tested for carto 3 system for a second time and passed.However, the root cause of the reversed icon remains unknown.Due to the char found, the catheter was tested for electrical performance, temperature response and stockert compatibility and 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 was confirmed.However, the root cause of the char remains unknown.

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 3732285
• MDR Text Key: 4275572
• Report Number: 9673241-2014-00136
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068/S6
• 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: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: D-1260-04-S
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 15972357M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1