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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/19/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported that during the procedure, a small pericardial effusion was noticed.The effusion was minor and was not problematic at the beginning of the procedure.The reporter stated that when mapping in the lv, the catheter went somewhere outside the lv.It was noted that the catheter may have gone into the pericardial space.The patient then started to have a drop in blood pressure.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.The patient was reported to be in stable condition.Since the event (cardiac tamponade) is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information received on 26-jan-2022.It was reported that the patient is male and was born on (b)(6) 1942.Therefore, a.2.Date of birth and a.3.Gender were updated.The physician name was provided.Therefore, e 1.Initial reporter title, e1.Initial reporter first name, e.1.Initial reporter last name, e.2.Health professional? and e.3.Initial reporter occupation were updated.It was also reported that the adverse event was discovered during mapping use of the product and no ablation was completed during the case.The physician¿s opinion regarding this adverse event is that the patient condition was the perceived cause.Thin left ventricle (lv) and established effusion present at start of procedure.The physician did not think that the adverse event had anything to do with biosense webster inc.(bwi) product issues.The patient outcome is uncertain at the time of reporting.The pericardial effusion was getting worse during the procedure after the incident, and it was determined that ct surgery was necessary.The reporter believes that the patient made a full recovery after surgery.The patient required extended hospitalization because of the adverse event.The patient required ct surgery.¿stay would be extended but i believe it was an inpatient.¿ therefore, the h6.Health effect - impact code was updated.Generator information was provided as stockert smart ablate generator - g4cp4272-a.A transseptal puncture was performed with a st.Jude abbott - brk-1.Therefore, the concomitant product section was updated.No ablation was performed.No evidence of a steam pop.The event occurred during the mapping phase.An irrigated catheter was used in the event and the flow setting were 2 ml/min.Standard setting for ablation with stsf but no ablation, (8 ml/min < 31, 15 ml/min >30).The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features were used: graph, dashboard, vector and no visitag since no ablations were completed.Color options used prospectively was impedance.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) was performed for the finished device 30642967l number, and no internal action related to the complaint was found during the review.Based on the mre, the d.4.Expiration date and h.4.Device manufacture date were updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13007332
• MDR Text Key: 285354899
• Report Number: 2029046-2021-02191
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30642967L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2021
• 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: SMARTABLATE PUMP KIT-WW; UNK ST. JUDE ABBOTT BRK-1 NEEDLE; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male