MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device with lot number 30251632l, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-04047 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter), mfr # 2029046-2019-04048 for product code r7f282ct (decanav electrophysiology catheter).

Event Description

It was reported that a female patient, over (b)(6) years old, underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a decanav electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.Patient had a history of recurrent episodes of palpitations which were found to be premature ventricular ectopic beats.This was the second electrophysiology procedure for the patient for same reason.The carto 3 system and smartablate generator were setup with standard setup.During the procedure, the patient was prepared, sedated and catheters were inserted via femoral vein and artery.Transseptal puncture was performed using an abbott needle (unknown model).Using the thermocool® smart touch® sf bi-directional navigation catheter, decanav electrophysiology catheter and agilis steerable sheath (st jude medical), the aortic root was mapped and an early signal on left coronary cusp was found.Therefore, ablation was performed in that area, which resulted in suppression of most frequent pvc.The smartablate radiofrequency generator settings were power control mode, 35-40w, timer at 120 seconds but time limit was not reached during any application.Physician then was chasing a second pvc on the coronary sinus with both thermocool® smart touch® sf bi-directional navigation catheter and decanav electrophysiology catheter.At certain point a shadow was seen on x-ray around pericardium indicating a possible cardiac tamponade which was confirmed using a philips echocardiogram machine.A pericardiocentesis was performed and drain was setup.Blood was aspirated and put it back into patient blood stream via femoral artery access.Patient¿s blood pressure was stable during whole procedure.Rest of catheters and sheaths were removed, groin was treated as per normal protocol.Patient was sent to intensive care unit and expected to be hospitalized for an extended time of 1 ¿ 2 days after procedure.The patient fully recovered with no residual effects.The thermocool® smart touch® sf bi-directional navigation catheter irrigation was set to standard flow settings: 8ml/min and 15ml/min.The force visualization features used were graph, dashboard, vector and visitag.The visitag stability parameters used were range: 25mm, time: 3 sec., force over time (fot): 25% of 3gr and tag size: 3mm.Force time interval (fti) color options were used, however, no additional visitag filters were used.Physician assessment was that coronary sinus vein was probably perforated during normal catheter and/or sheath movement within vein.Physician expressed that biosense webster catheters were functioning as intended and no error messages were observed.And reported the event occurred during the mapping phase.There was no evidence of any steam pops.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9504510
• MDR Text Key: 188855081
• Report Number: 2029046-2019-04047
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30251632L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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