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 Problem Use of Device Problem (1670)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/15/2017

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.Concomitant products: st.Jude medical brk-1 transseptal needle.Mobicath small curve 8.5fr sheath, model # d-1400-10.(b)(4) are related to the same incident.Force sensor error 106 displayed on the carto 3 system.Cables were replaced twice with a new and a reprocessed cable without resolution.Catheter was replaced without resolution.Patient interface unit (piu) was rebooted and the study was reloaded without resolution.Case continued without using the force component of the catheter.After the case was completed, the bwi representative reported that a new test study was launched and the issue remained.There is no information regarding spi value, catheter proximity, or carto indicating to re-zero.Smarttouch catheter was not zeroed after the initial warm-up phase, post-connection to the carto 3 patient interface unit, as error 106 occurred.Since both thermocool smarttouch bi-directional sf catheters may have been in the patient¿s body prior to the injury, bwi is taking a conservative approach by reporting under both.

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation with two thermocool smarttouch bi-directional sf catheters and suffered a cardiac tamponade requiring pericardiocentesis.Post-procedure, a tamponade was confirmed via intracardiac echocardiogram and echocardiogram.Pericardiocentesis yielded 450 cc.Patient was reported to be in stable condition.Patient required one additional day of extended hospitalization as a result of the adverse event.Patient fully recovered.It was noted that the patient was in sinus rhythm during the procedure.It was noted that the event may have occurred during mapping or ablation phase.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Transseptal puncture was performed with a st.Jude medical brk-1 transseptal needle.Sheath in use was a mobicath 8.5 french.Generator parameters included power control mode at 25 watts on the posterior wall and 30 watts on the anterior wall with temperature cut-off at 40 degrees celsius.Overall ablation time and last ablation cycle time at the site of injury were not reported, as the time of injury is unknown.Irrigated catheter flow was set on 8 ml/min while ablating at 30 watts or less and 15 ml/min while ablating at greater than 30 watts.Patient received anticoagulant during the procedure with activated clotting time maintained between 250-300 seconds.

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation with two thermocool smarttouch bi-directional sf catheters and suffered a cardiac tamponade requiring pericardiocentesis.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.Deflection and irrigation tests were performed, which the catheter passed.No occlusion was observed.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, but error 106 (force sensor failure) was displayed.The catheter was then dissected, and it was determined that the root cause was an internal sensor failure.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.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 root cause of the internal sensor failure cannot be determined, but it is not related to the cardiac tamponade suffered by the patient, the root cause of which is also unknown.The instructions for use state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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: 6407328
• MDR Text Key: 70019639
• Report Number: 9673241-2017-00210
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)160604(17)170531(10)17488780L
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• 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: 17488780L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2016
• 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
• Patient Age: 63 YR
• Patient Weight: 106