MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-05-S

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Cardiac Arrest (1762)

Event Date 03/30/2017

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.The device history record (dhr) for the lot number 17642280m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a male patient, approximately (b)(6), underwent an ablation procedure for persistent supraventricular tachycardia and atrial flutter with a thermocool smarttouch bi-directional navigation catheter and suffered a broken lead cardiac pacemaker (requiring transcutaneous pacing and lead replacement) and asystolic cardiac arrest (requiring cardiopulmonary resuscitation).During the procedure, while ablating in the coronary sinus, a permanent pacemaker lead became dislodged and the patient became asystolic.Cardiopulmonary resuscitation (cpr) was performed.Transcutaneous pacing was initiated.A cardiology fellow increased the capture threshold on the permanent pacemaker and the issue temporarily resolved.Remainder of procedure was aborted.Later that evening, a new pacemaker lead was implanted.Patient likely required extended hospitalization as a result of the adverse event for recovery from pacemaker lead replacement.Patient fully recovered with no residual effects and was discharged from the hospital.It was noted that the patient had a dilated coronary sinus.Physician¿s opinion regarding the cause of the adverse event is that it was not the fault of the thermocool smarttouch bi-directional navigation catheter.The physician indicated that he inadvertently dislodged the pacemaker lead that was only a few weeks old.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 5/3/17.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

Manufacturer's ref.No: (b)(4).It was reported that a male patient, approximately (b)(4), underwent an ablation procedure for persistent supraventricular tachycardia and atrial flutter with a thermocool smarttouch bi-directional navigation catheter.During the procedure, while ablating in the coronary sinus, a permanent pacemaker lead became dislodged and the patient became asystolic.Cardiopulmonary resuscitation (cpr) was performed.Transcutaneous pacing was initiated.A cardiology fellow increased the capture threshold on the permanent pacemaker and the issue temporarily resolved.Remainder of procedure was aborted.Later that evening, a new pacemaker lead was implanted.Patient likely required extended hospitalization as a result of the adverse event for recovery from pacemaker lead replacement.Patient fully recovered with no residual effects and was discharged from the hospital.It was noted that the patient had a dilated coronary sinus.The physician indicated that he inadvertently dislodged the pacemaker lead that was only a few weeks old.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was evaluated for screening test and catheter passed.The force feature was working properly.Finally, the force sensor values were found within specifications.Then the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Additionally, a deflection and an irrigation test were performed and the catheter passed the tests.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 passed all specifications.According to the information received, the root cause of the adverse event could be related to the physician method.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 6508967
• MDR Text Key: 73334596
• Report Number: 9673241-2017-00304
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)170225(17)180131(10)17642280M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• 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-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17642280M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR