MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) THERMOCOOL® SF BI-DIRECTIONAL CATHETER

Model Number D-1314-00

Device Problem Use of Device Problem (1670)

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

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

Event description continuation: mapping was performed in the left ventricle and in the pericardial space.Bipolar ablation was performed during sinus rhythm using a thermocool® smarttouch® bi-directional navigation catheter on the endocardium and a thermocool® sf bi-directional catheter on the epicardium.Contact force was kept between 10 and 20 grams on both surfaces.During radiofrequency energy application, the maximum power was 35 watts and the maximum duration was 90 seconds.A total of 7 minutes of bipolar radiofrequency (rf) was applied.Patient received anticoagulant (heparin) during the procedure with activated clotting time maintained at greater than 250 seconds.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 products: carto 3 system (model# unknown lot# unknown).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for non-ischemic ventricular tachycardia with a thermocool® sf bi-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the final radiofrequency (rf) application, withdrawal of the irrigation fluid from the pericardial space changed from clear to bloody with a loss of dynamic motion of the left heart border.Perforation was suspected.Ablation was terminated.Anticoagulation was reversed with protamine.A pericardiocentesis was performed and yielded 1200cc of fluid and the pericardial bleeding stopped.Pigtail catheter was left within the pericardial space and attached to dependent drainage.Catheters and sheaths were removed.Hemostasis was obtained by manual compression.At no time was the systolic blood pressure less than 100 mmhg.Vasopressor support was not required.There was no further bleeding over the next hour of observation.There is no information regarding extended hospitalization.Physician did not provide a causality opinion.Physician noted that the thermocool smarttouch bi-directional navigation catheter felt stiff.Sheaths were inserted percutaneously into bilateral femoral veins for administration of intravenous fluids and introduction of catheters.A 7 french short sheath was inserted percutaneously into the right femoral artery for recording of arterial pressure and introduction of catheters.Pericardial space was accessed percutaneously via a sub-diaphragmatic micropuncture technique.An 8 french arrow sheath was placed in the pericardial space for mapping and ablation.Pericardial space was intermittently drained by manual suction.Multipolar catheters were positioned at the right ventricular apex, right ventricular outflow tract, his bundle, and high right atrium for pacing and recording.Endocardial and epicardial substrate mapping was performed using a carto 3 system.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6314701
• MDR Text Key: 66934598
• Report Number: 2029046-2017-00035
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1314-00
• Device Catalogue Number: D131400
• Device Lot Number: UNK_C3 ST TCOOL SF NON-NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2017
• 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): Life Threatening; Required Intervention