MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1266-01-S

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Atrial Fibrillation (1729)

Event Date 08/26/2015

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a navistar rmt thermocool electrophysiology catheter, there was noise signal on all channels being displayed on both equipments, carto and ep recording system, as well as an error message ("map cannot be built") and lacking of visualization.Troubleshooting was performed by replacing cables with no resolution.The procedure was completed by exchanging the catheter.There was no patient consequence.Additional information was requested in order to clarify if physician was able to monitor patient's heart rhythm; however, no further details were made available.Based on the current information, bwi determined to take a conservative approach and report this event since there was noise on all signals on both equipments.The lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a navistar® rmt thermocool® electrophysiology catheter, there was noise signal on all channels being displayed on both equipments, carto and ep recording system, as well as an error message ("map cannot be built") and lacking of visualization.Troubleshooting was performed by replacing cables with no resolution.The procedure was completed by exchanging the catheter.There was no patient consequence.Additional information was requested in order to clarify if physician was able to monitor patient¿s heart rhythm; however, no further details were made available.Based on the current information, bwi determined to take a conservative approach and report this event since there was noise on all signals on both equipments.The lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.The bwi failure analysis lab received the device for evaluation.Upon receipt, the catheter was visually inspected and it was found in normal conditions.The catheter was tested per the reported event on eeprom and calibration test and passed eeprom test but failed calibration test.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.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.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures the customer complaint was confirmed.The root cause does not appear to be manufactured related.Therefore no capa activity is requested.Similar complaints are monitored on monthly bases.

• Brand Name: NAVISTAR® RMT THERMOCOOL® 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5097013
• MDR Text Key: 26850031
• Report Number: 9673241-2015-00657
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17055934M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2015
• 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