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 Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Air Embolism (1697)

Event Date 10/25/2016

Event Type  Injury  

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 (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for paroxysmal atrial fibrillation with a thermocool smarttouch bi-directional navigation catheter and suffered an air embolism requiring no medical or surgical intervention.After introducing the smarttouch catheter through the transseptal puncture, an air bubble was observed in the left ventricle.It was noted that the catheter had not yet been flushed and that this was the likely cause of the air bubble.Procedure was successfully completed.There were no further patient consequences observed.Patient did not require extended hospitalization as a result of this adverse event.Patient fully recovered.Physician's opinion regarding the cause of the adverse event is that it was due to human error and in no way was related to any product malfunction.There were no issues reported with any bwi products or equipment.It was noted that the catheter performed properly.

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for paroxysmal atrial fibrillation with a thermocool smarttouch bi-directional navigation catheter and suffered an air embolism requiring no medical or surgical intervention.The returned device was visually inspected and was found in good condition.Per the reported event, the catheter was tested for electrical performance, temperature response and generator compatibility, and it was found within specifications.A deflection test was performed, which the catheter passed.The catheter was evaluated for eeprom, and the sensor functionality was tested on a carto 3 system.The catheter was recognized by the carto 3 system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.The force feature was evaluated and passed.Finally, an irrigation test was performed, which the catheter passed.No occlusion was observed.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.The root cause of air embolism remains unknown.

• 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: 6108166
• MDR Text Key: 60076806
• Report Number: 9673241-2016-00787
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)160809(17)170731(10)17521461M
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P030031/S053
• 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
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17521461M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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
• Patient Age: 35 YR
• Patient Weight: 85