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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) with history of left ventricle apex of aneurysm underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool¿ smart touch¿ sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported that during a idvt procedure the pressure dropped and the catheter was thought to have went through the left ventricle.A pericardial effusion was diagnosed via transesophageal echo (tte).A pericardiocentesis was performed by the physician.The patient was stable at the time of the call and was transferred to intensive care unit (icu) for observation.The catheter will be sent in for analysis.The adverse event happened during the ablation.Physician was not certain it was from the ablation catheter.He thought it was possible that the catheter in right ventricle (rv) could have caused the event.The patient had fully recovered.The transseptal was performed with brk1 needle.There was no evidence of stem pop.Standard irrigation settings were used (2ml, 8ml and 15ml per min).There were no error messages observed on biosense webster equipment during the procedure.Graph, dashboard and vector were used for force visualization.Since this cardiac tamponade may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is 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; 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 10981792
• MDR Text Key: 221278487
• Report Number: 2029046-2020-01821
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 11/13/2020

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 Expiration Date: 08/19/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30423294M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR