MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.(b)(4).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: mfr # 2029046-2020-01127 for product code d133602 (thermocool® smart touch¿ electrophysiology catheter).Mfr # 2029046-2020-01577 for product code d133601 (thermocool® smart touch¿ electrophysiology catheter).

Event Description

It was reported that a (b)(6) old male patient (98kg) underwent an atrioventricular reentrant tachycardia (avrt) ablation procedure with two (2) thermocool® smart touch¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that during the procedure while ablating, the physician noticed 1 cm pericardial effusion.It was also reported that several high force warnings were highlighted to the physician during the procedure (approx.70g).Body coordinate system (bcs) was reset due to patient movement as a result of agitation/ pain.Post-procedure, cardiac tamponade was confirmed by echocardiography.Pericardiocentesis was performed to drain 300 ml of blood from the pericardial space.The patient stabilized after pericardial drainage and was admitted to intensive care unit (icu) and then transferred to another hospital.Surgical intervention was later required.Extended hospitalization was required for observation.Physician¿s opinion regarding the cause of the adverse event is that it was due to a combination of difficult to reach tachycardia location and patient movement due to discomfort.Transseptal puncture was performed with a brk-1 transseptal needle (st.Jude medical) and safesept transseptal guide wire.The force visualization features used included dashboard, vector and visitag.The visitag module with settings at range 3mm, time 3 sec, force over time (fot) 25%, minimum force 3gm, tag display: time.There was no evidence of steam pop during the ablation.Standard smart touch irrigation settings were used throughout the case.The customer¿s reported high force issue has been assessed as not mdr reportable as it is highly detectable when occurring.The potential risk that it could cause or contribute to a death or serious injury is remote.Additional information was received indicating that two ablation catheters were used during the procedure (one smarttouch thermocool f curve & one smarttouch thermocool d curve).Additional follow up was sent to clarify which catheter was in use at the time of the injury.On 9/30/2020, additional information was received that since the pericardial effusion was found after the procedure was finished, therefore, it wasn¿t clear when or with which catheter the injury occurred.Based on the information received on 9/30/2020, the decision has been made to reported the adverse event under both ablation catheters.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY 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: 10744597
• MDR Text Key: 213460941
• Report Number: 2029046-2020-01577
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CARTO 3 SYSTEM; SAFESEPT TRANSSEPTAL GUIDE WIRE; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; ST. JUDE MEDICAL -- BRK-1 TRANSSEPTAL NEEDLE; THMCL SMARTTOUCH,TC,F,C3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98