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

Model Number D-1348-05-S

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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 female patient underwent an idiopathic ventricular tachycardia ablation procedure for premature ventricular contractions (pvcs) with a thermocool® smarttouch® sf bi-directional nav catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, at the conclusion of the case, a tamponade was confirmed via echocardiogram.A pericardiocentesis was performed and yielded 250cc of fluid.Patient was reported to be in stable condition.Patient required extended hospitalization as a result of this adverse event.Patient outcome is improved.There were no known factors cited that may have contributed to the adverse event.Physician was unsure of causality of event.Transseptal puncture was performed with a st.Jude medical brk-1 xs transseptal needle.Sheath used was a st.Jude medical agilis nxt 8.5 french large curl.Generator parameters at the time of injury included power control mode with power cut-off of 35 watts.Overall ablation time and last ablation cycle time were not reported, as the site of injury is unknown.Irrigated catheter flow was set at 15ml/min for ablation at 35 watts.Patient received anticoagulant (heparin) with an unknown activated clotting time.Smarttouch catheter was zeroed after the initial warm-up phase, post-connection to the carto 3 patient interface unit.It was also reported that the error message "invalid catheter id detected" was being displayed on the soundstar catheter.Soundstar catheter was connected to both the carto and the ultrasound system when the error occurred.Mapping catheter was connected to the carto prior to connecting the soundstar catheter.Cartosound/uls was selected on the carto system.The cable was replaced without resolution.The catheter was replaced and the issue resolved.This error is not mdr reportable as the risk to the patient is low.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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: 6255024
• MDR Text Key: 64926345
• Report Number: 9673241-2017-00056
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)160531(17)170531(10)17475284L
• 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
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17475284L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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): Hospitalization; Life Threatening; Required Intervention