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 Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/22/2016

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 patient, (b)(6), male, underwent a left sided atrial flutter procedure with a thermocool smarttouch bi-directional navigation catheter and suffered a cardiac tamponade, which required pericardiocentesis.While mapping and ablating the left atrial flutter, the patient suffered a pericardial effusion.A decrease in the patient¿s blood pressure was noted and the effusion was confirmed using intracardiac echocardiogram.The effusion was noticed during ablation; however it is unknown when the injury occurred.A pericardiocentesis was immediately performed and the patient was stable at the time this event was reported.The physician believes the injury is procedure related and may have occurred while ablating the posterior mitral isthmus area, as the ablation catheter appeared outside of the geometry at that area.A transseptal puncture was performed with an unknown needle.The patient did received anticoagulant during the procedure and the activated clotting time was maintained at 250-350s.An agilis sheath was used during the procedure.The generator was in power control mode with a temperature cutoff of 47°c.The power was at 15-30 watts depending on location and was not titrated.The irrigated flow setting was 30ml/min for all power settings.There were no errors reported by the biosense webster systems during the procedure.There are no known factors that might have contributed to the event.

Manufacturer Narrative

(b)(4).It was reported that a patient, (b)(6), male, underwent a left sided atrial flutter procedure with a thermocool® smarttouch® bi-directional navigation catheter and suffered a cardiac tamponade, which required pericardiocentesis.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 generator test and it was found within specifications.A deflection test was performed and the catheter passed.The catheter functionality of the sensors were tested on the carto 3 system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was evaluated and passed.An irrigation test was performed and 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 the tamponade remains unknown.The instructions for use 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: 5946985
• MDR Text Key: 54581747
• Report Number: 9673241-2016-00582
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)160708(17)170630(10)17514993M
• 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
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17514993M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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; Required Intervention
• Patient Age: 64 YR