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 Pseudoaneurysm (2605)

Event Date 11/15/2021

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 finished device (b)(4) number, no internal action was found during the review.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 an unknown patient underwent a supraventricular tachycardia (svt) ablation procedure with a (b)(6) bi-directional navigation catheter.The patient suffered a pseudoaneurysm.It was reported that after the procedure was completed, the physician was examining the access site with ultrasound (vascular probe) in preparation for placing a closure device and that a pseudoaneurysm was discovered.The patient did not exhibit any symptoms.It is unclear whether the pseudoaneurysm is the result of this procedure or a cardiac cath the patient had 3-4 weeks ago.Another physician has been called to assist with treatment- type of treatment not known at this time.The patient is stable at this time.Other bwi products in use: pentaray, soundstar, vizigo, cardiaguide, and esophastar.Ablation catheter has been discarded.It was reported that the sensor housings on the green patch sensor cable are worn, and it is difficult to keep them in place when connected to the patches.The procedure was able to be completed.Conservatively this will be reportable based on the information that another physician was called to help with treatment and will be reevaluated as new information is provided.This adverse event was discovered post use of biosense webster products, when closing access sites.The physician¿s opinion on the cause of this adverse event is the procedure.Medical intervention provided: thrombin was injected into the aneurysm.According to the reporter the patient outcome of the adverse event is stable, last they were aware.Generator information: smartablate.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it 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: 12954414
• MDR Text Key: 286254172
• Report Number: 2029046-2021-02127
• 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: 12/07/2021

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 Expiration Date: 06/24/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30589230L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: CARDIOGUIDE.; CARTO 3 SYSTEM.; ESOPHASTAR.; PENTARAY NAV CATHETER.; SOUNDSTAR ECO CATHETER.; VIZIGO SHEATH.
• Patient Outcome(s): Life Threatening; Required Intervention