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

Model Number D-1197-17-S

Device Problem Impedance Problem (2950)

Patient Problem Complete Heart Block (2627)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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 ablation procedure for right sided atrial flutter with a navistar® thermocool®electrophysiology catheter and suffered third degree heart block requiring a permanent pacemaker.At the onset of ablation, a non mdr reportable impedance issue occurred as impedance readings disappeared several times for a few seconds.After changing position, impedance was stable again and ablation was resumed.It was felt that the atrioventricular node must have been ablated since the patient had an atrioventricular block requiring pacemaker implantation.The physician chose to complete the case with modifications, conducting a right-side atypical flutter ablation.The patient was reported to be in stable condition at the time the complaint was reported.The physician's opinion regarding the cause of the adverse event is that it was not related to the catheter.There were no complaints of any biosense webster equipment during the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/20/2016.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

(b)(4).It was reported that a patient underwent an ablation procedure for right sided atrial flutter with a navistar® thermocool® electrophysiology catheter and suffered third degree heart block requiring a permanent pacemaker.At the onset of ablation, a non mdr reportable impedance issue occurred as impedance readings disappeared several times for a few seconds.After changing position, impedance was stable again and ablation was resumed.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.An irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The catheter was also evaluated for carto 3.The catheter was tested for eeprom and the magnetic sensor functionality.The catheter failed during the magnetic sensor functionality test.Further examination showed that the sensor was within specifications.According to the calibration results and the sensor readings, the improper condition was attributed to a potential pc board failure.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 catheter failed during the magnetic sensor functionality test.Based on available analysis results, it could not be identified whether the issue is related to an internal or an external cause.The root cause of the heart block remains unknown.The customer complaint regarding an impedance issue cannot be confirmed.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/20/2016.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).

• Brand Name: NAVISTAR® 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: 5398739
• MDR Text Key: 37107061
• Report Number: 9673241-2016-00053
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 17182753M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2015
• 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
• Patient Outcome(s): Life Threatening; Required Intervention