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 Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent an idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and liver injury requiring surgical intervention.An adverse event from a case that took place on (b)(6) 2021.The reporter states during the case on (b)(6) 2021 there were no complications during the case.They were notified today that while the patient was in the icu, their blood pressure dropped and the patient had a pericardial effusion which was confirmed by an ultrasound.The caller states a pericardiocentesis was done.The reported does not know how much fluid was removed from the patient during the pericardiocentesis.The reporter states the bleeding was not from the heart.They had gotten epicardial access during the ep procedure and they lacerated part of the liver.The caller states they mapped part of the left ventricle both epi-cardialy and endo-cardialy.They mapped and ablated in the left ventricle.The caller states the patient went to interventional radiology where they had an embolization procedure of the bleeding vessel.The caller states the patient is now stable and remains in the hospital.The patient is now free of ventricle tachycardia.The reporter does not think the physician feels any of the bwi products are at fault for the issue.The adverse event was discovered after the procedure while after the patient was transferred back to the icu.The physician¿s opinion on the cause of this adverse event: procedure, obtaining access to the pericardial sac for mapping and ablation.A transseptal puncture was performed with an unknown device.Prior to noting the ct ablation was performed.There was no evidence of steam pop.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.Force visualization features used: graph, dashboard, vector and visitag.The visitag module parameters for stability were used: 3sec, 3mm, 25% at 3grams.No additional filters were used and impedance was used for color options prospectively.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• 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: 12192825
• MDR Text Key: 265641699
• Report Number: 2029046-2021-01141
• 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: Other
• Type of Report: Initial
• Report Date: 06/29/2021

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: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/19/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention