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 Mechanical Problem (1384)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

Smarttouch catheter was in close proximity to another catheter during cti ablation, but not post-cti ablation, when the tamponade was discovered.Smarttouch catheter was zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit.There is no information regarding the carto 3 system indicating to re-zero the catheter.There were no errors reported on any bwi equipment during the procedure.Since two ablation catheters were used prior to the adverse event, this event is being reported under both catheters.This complaint is for the first catheter used with the temperature issue.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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant: st.Jude medical transseptal needle.St.Jude medical agilis long curve sheath.Smartablate generator.Full udi # information unavailable since the lot number is unknown.(b)(4) are related to the same incident.

Event Description

It was reported that a male patient underwent a cavotricuspid isthmus (cti) ablation procedure for atrial flutter with two thermocool® smarttouch® bi-directional navigation catheters and suffered a cardiac tamponade requiring pericardiocentesis.Prior to the adverse event, there was no temperature displayed on the smartablate generator.The smarttouch catheter was replaced and the issue resolved.This event is not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.During the procedure, while using smarttouch catheter #2, the patient became hypotensive and a tamponade was confirmed via ultrasound while screening the right atrium, right ventricle, and left ventricle.A pericardiocentesis was performed and yielded approximately 2000 ml of fluid.Patient was reported to be in stable condition.Patient required an overnight stay in the hospital for monitoring.Patient has fully recovered.It was noted that there was no baseline effusion and that the injury occurred post-cti ablation, while returning to the left atrium.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 a result of a mechanical tear or product handling.Transseptal puncture was performed with a st.Jude medical transseptal needle.Sheath used was a st.Jude medical agilis long curve.Generator was set on power control mode at 25-30 watts with contact force ranging from 10-20 grams.There is no information regarding generator settings at the time of injury, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, or irrigated catheter flow setting.Patient received anticoagulant during the procedure with an activated clotting time that decreased and was eventually raised to the 100s (seconds).

• 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: 6639851
• MDR Text Key: 77536087
• Report Number: 9673241-2017-00466
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: UNK_D-1327-05-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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